Trial Outcomes & Findings for Cross-linking for Corneal Ulcers Treatment Trial (NCT NCT02570321)
NCT ID: NCT02570321
Last Updated: 2025-06-18
Results Overview
Corneal scraping of the ulcer will be performed and directly inoculated on to sheep's blood agar, chocolate agar, potato dextrose agar or Sabouraud's agar for bacterial and fungal culture. Microbiological cure is defined as no growth of bacteria or fungus on these media.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
147 participants
Primary outcome timeframe
4 to 24 hours after enrollment
Results posted on
2025-06-18
Participant Flow
Participant milestones
| Measure |
Bacterial Ulcer Control
Standard of care topical treatment for bacterial ulcer
Bacterial ulcer control: For those bacterial ulcer subjects randomized to the control group, they will receive the standard of care topical treatment for bacterial ulcers. This group will have their eyes irrigated with a balanced salt solution.
|
Bacterial Ulcer Cross-linking
Standard of care topical treatment for bacterial ulcer plus cross-linking
Bacterial ulcer cross-linking: For those subjects randomized to receive collagen cross-linking, the procedure will be performed as per the routine at the hospital (UV-X machine; strict aseptic precautions; corneal epithelium debrided and 0.1% riboflavin applied for 30 minutes, then UV-A radiation applied for 30 minutes at 370nm with 3mW/cm2). Corneal cross-linking is a routine procedure performed by Aravind Eye Hospital for infectious keratitis.
|
Fungal Ulcer Control With Natamycin
Standard of care topical treatment for fungal ulcer with natamycin
Fungal ulcer control: Prior to receiving sham cross-linking, topical amphotericin B or topical natamycin antifungal therapy will be started as per routine at the hospital; a loading dose of amphotericin B or natamycin every 5 minutes x 6 will be followed by dosing every 30 minutes. Amphotericin B and natamycin are routinely used therapies for fungal keratitis at Aravind Eye Hospital.
For those fungal ulcer subjects randomized to the control group, they will receive the standard of care topical treatment for fungal ulcers. This group will have their eyes irrigated with a balanced salt solution.
|
Fungal Ulcer Cross-linking Plus Natamycin
Standard of care topical treatment for fungal ulcer with natamycin plus cross-linking
Fungal ulcer cross-linking: Prior to receiving cross-linking, topical amphotericin B or topical natamycin antifungal therapy will be started as per routine at the hospital; a loading dose of amphotericin B or natamycin every 5 minutes x 6 will be followed by dosing every 30 minutes. Amphotericin B and natamycin are routinely used therapies for fungal keratitis at Aravind Eye Hospital.
For those subjects randomized to receive collagen cross-linking, the procedure will be performed as per the routine at the hospital (UV-X machine; strict aseptic precautions; corneal epithelium debrided and 0.1% riboflavin applied for 30 minutes, then UV-A radiation applied for 30 minutes at 370nm with 3mW/cm2). Corneal cross-linking is a routine procedure performed by Aravind Eye Hospital for infectious keratitis.
|
Fungal Ulcer Control With Amphotericin
Standard of care topical treatment for fungal ulcer with amphotericin
Fungal ulcer control: Prior to receiving sham cross-linking, topical amphotericin B or topical natamycin antifungal therapy will be started as per routine at the hospital; a loading dose of amphotericin B or natamycin every 5 minutes x 6 will be followed by dosing every 30 minutes. Amphotericin B and natamycin are routinely used therapies for fungal keratitis at Aravind Eye Hospital.
For those fungal ulcer subjects randomized to the control group, they will receive the standard of care topical treatment for fungal ulcers. This group will have their eyes irrigated with a balanced salt solution.
|
Fungal Ulcer Cross-linking Plus Amphotericin
Standard of care topical treatment for fungal ulcer with amphotericin plus cross-linking
Fungal ulcer cross-linking: Prior to receiving cross-linking, topical amphotericin B or topical natamycin antifungal therapy will be started as per routine at the hospital; a loading dose of amphotericin B or natamycin every 5 minutes x 6 will be followed by dosing every 30 minutes. Amphotericin B and natamycin are routinely used therapies for fungal keratitis at Aravind Eye Hospital.
For those subjects randomized to receive collagen cross-linking, the procedure will be performed as per the routine at the hospital (UV-X machine; strict aseptic precautions; corneal epithelium debrided and 0.1% riboflavin applied for 30 minutes, then UV-A radiation applied for 30 minutes at 370nm with 3mW/cm2). Corneal cross-linking is a routine procedure performed by Aravind Eye Hospital for infectious keratitis.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
19
|
17
|
26
|
27
|
30
|
28
|
|
Overall Study
COMPLETED
|
17
|
16
|
21
|
27
|
27
|
25
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
5
|
0
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cross-linking for Corneal Ulcers Treatment Trial
Baseline characteristics by cohort
| Measure |
Bacterial Ulcer Control
n=19 Participants
Standard of care topical treatment for bacterial ulcer
Bacterial ulcer control: For those bacterial ulcer subjects randomized to the control group, they will receive the standard of care topical treatment for bacterial ulcers. This group will have their eyes irrigated with a balanced salt solution.
|
Bacterial Ulcer Cross-linking
n=17 Participants
Standard of care topical treatment for bacterial ulcer plus cross-linking
Bacterial ulcer cross-linking: For those subjects randomized to receive collagen cross-linking, the procedure will be performed as per the routine at the hospital (UV-X machine; strict aseptic precautions; corneal epithelium debrided and 0.1% riboflavin applied for 30 minutes, then UV-A radiation applied for 30 minutes at 370nm with 3mW/cm2). Corneal cross-linking is a routine procedure performed by Aravind Eye Hospital for infectious keratitis.
|
Fungal Ulcer Control With Natamycin
n=26 Participants
Standard of care topical treatment for fungal ulcer with natamycin
Fungal ulcer control: Prior to receiving sham cross-linking, topical amphotericin B or topical natamycin antifungal therapy will be started as per routine at the hospital; a loading dose of amphotericin B or natamycin every 5 minutes x 6 will be followed by dosing every 30 minutes. Amphotericin B and natamycin are routinely used therapies for fungal keratitis at Aravind Eye Hospital.
For those fungal ulcer subjects randomized to the control group, they will receive the standard of care topical treatment for fungal ulcers. This group will have their eyes irrigated with a balanced salt solution.
|
Fungal Ulcer Cross-linking Plus Natamycin
n=27 Participants
Standard of care topical treatment for fungal ulcer with natamycin plus cross-linking
Fungal ulcer cross-linking: Prior to receiving cross-linking, topical amphotericin B or topical natamycin antifungal therapy will be started as per routine at the hospital; a loading dose of amphotericin B or natamycin every 5 minutes x 6 will be followed by dosing every 30 minutes. Amphotericin B and natamycin are routinely used therapies for fungal keratitis at Aravind Eye Hospital.
For those subjects randomized to receive collagen cross-linking, the procedure will be performed as per the routine at the hospital (UV-X machine; strict aseptic precautions; corneal epithelium debrided and 0.1% riboflavin applied for 30 minutes, then UV-A radiation applied for 30 minutes at 370nm with 3mW/cm2). Corneal cross-linking is a routine procedure performed by Aravind Eye Hospital for infectious keratitis.
|
Fungal Ulcer Control With Amphotericin
n=30 Participants
Standard of care topical treatment for fungal ulcer with amphotericin
Fungal ulcer control: Prior to receiving sham cross-linking, topical amphotericin B or topical natamycin antifungal therapy will be started as per routine at the hospital; a loading dose of amphotericin B or natamycin every 5 minutes x 6 will be followed by dosing every 30 minutes. Amphotericin B and natamycin are routinely used therapies for fungal keratitis at Aravind Eye Hospital.
For those fungal ulcer subjects randomized to the control group, they will receive the standard of care topical treatment for fungal ulcers. This group will have their eyes irrigated with a balanced salt solution.
|
Fungal Ulcer Cross-linking Plus Amphotericin
n=28 Participants
Standard of care topical treatment for fungal ulcer with amphotericin plus cross-linking
Fungal ulcer cross-linking: Prior to receiving cross-linking, topical amphotericin B or topical natamycin antifungal therapy will be started as per routine at the hospital; a loading dose of amphotericin B or natamycin every 5 minutes x 6 will be followed by dosing every 30 minutes. Amphotericin B and natamycin are routinely used therapies for fungal keratitis at Aravind Eye Hospital.
For those subjects randomized to receive collagen cross-linking, the procedure will be performed as per the routine at the hospital (UV-X machine; strict aseptic precautions; corneal epithelium debrided and 0.1% riboflavin applied for 30 minutes, then UV-A radiation applied for 30 minutes at 370nm with 3mW/cm2). Corneal cross-linking is a routine procedure performed by Aravind Eye Hospital for infectious keratitis.
|
Total
n=147 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
59 years
n=7 Participants
|
50 years
n=5 Participants
|
55 years
n=4 Participants
|
45 years
n=21 Participants
|
56 years
n=10 Participants
|
54.5 years
n=115 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
63 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
17 Participants
n=10 Participants
|
84 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
28 Participants
n=10 Participants
|
147 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Region of Enrollment
India
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
28 Participants
n=10 Participants
|
147 Participants
n=115 Participants
|
|
Occupation
Agriculture
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
80 Participants
n=115 Participants
|
|
Occupation
Nonagriculture
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
15 Participants
n=10 Participants
|
66 Participants
n=115 Participants
|
|
Occupation
NA
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Medication use at enrollment
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
24 Participants
n=10 Participants
|
100 Participants
n=115 Participants
|
|
Affected Eye
Left
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
70 Participants
n=115 Participants
|
|
Affected Eye
Right
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
15 Participants
n=10 Participants
|
77 Participants
n=115 Participants
|
|
Visual acuity
|
1.7 LogMar
n=5 Participants
|
1.7 LogMar
n=7 Participants
|
1.05 LogMar
n=5 Participants
|
1.1 LogMar
n=4 Participants
|
1.05 LogMar
n=21 Participants
|
1.22 LogMar
n=10 Participants
|
1.1 LogMar
n=115 Participants
|
|
Ulcer location
Central
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
22 Participants
n=10 Participants
|
119 Participants
n=115 Participants
|
|
Ulcer location
Peripheral
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
27 Participants
n=115 Participants
|
|
Ulcer location
NA
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Infiltrate and/or scar
|
3.5 mm
n=5 Participants
|
3 mm
n=7 Participants
|
3.0 mm
n=5 Participants
|
3.9 mm
n=4 Participants
|
3.5 mm
n=21 Participants
|
3.1 mm
n=10 Participants
|
3.3 mm
n=115 Participants
|
|
Hypopyon
No
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
14 Participants
n=10 Participants
|
76 Participants
n=115 Participants
|
|
Hypopyon
<0.5 mm
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
|
Hypopyon
>=0.5 mm
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
56 Participants
n=115 Participants
|
|
% Depth
>0-33%
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
60 Participants
n=115 Participants
|
|
% Depth
>33-67%
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
19 Participants
n=10 Participants
|
79 Participants
n=115 Participants
|
|
% Depth
>67-100%
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
|
% Depth
NA
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Epithelial defect
|
3.2 mm
n=5 Participants
|
3 mm
n=7 Participants
|
3.0 mm
n=5 Participants
|
3.9 mm
n=4 Participants
|
3.5 mm
n=21 Participants
|
3.4 mm
n=10 Participants
|
3.2 mm
n=115 Participants
|
|
Duration of symptoms
|
3 days
n=5 Participants
|
4 days
n=7 Participants
|
5 days
n=5 Participants
|
7 days
n=4 Participants
|
5 days
n=21 Participants
|
4 days
n=10 Participants
|
5 days
n=115 Participants
|
PRIMARY outcome
Timeframe: 4 to 24 hours after enrollmentCorneal scraping of the ulcer will be performed and directly inoculated on to sheep's blood agar, chocolate agar, potato dextrose agar or Sabouraud's agar for bacterial and fungal culture. Microbiological cure is defined as no growth of bacteria or fungus on these media.
Outcome measures
| Measure |
Bacterial Ulcer Control
n=19 Participants
Standard of care topical treatment for bacterial ulcer
Bacterial ulcer control: For those bacterial ulcer subjects randomized to the control group, they will receive the standard of care topical treatment for bacterial ulcers. This group will have their eyes irrigated with a balanced salt solution.
|
Bacterial Ulcer Cross-linking
n=16 Participants
Standard of care topical treatment for bacterial ulcer plus cross-linking
Bacterial ulcer cross-linking: For those subjects randomized to receive collagen cross-linking, the procedure will be performed as per the routine at the hospital (UV-X machine; strict aseptic precautions; corneal epithelium debrided and 0.1% riboflavin applied for 30 minutes, then UV-A radiation applied for 30 minutes at 370nm with 3mW/cm2). Corneal cross-linking is a routine procedure performed by Aravind Eye Hospital for infectious keratitis.
|
Fungal Ulcer Control With Natamycin
n=26 Participants
Standard of care topical treatment for fungal ulcer with natamycin
Fungal ulcer control: Prior to receiving sham cross-linking, topical amphotericin B or topical natamycin antifungal therapy will be started as per routine at the hospital; a loading dose of amphotericin B or natamycin every 5 minutes x 6 will be followed by dosing every 30 minutes. Amphotericin B and natamycin are routinely used therapies for fungal keratitis at Aravind Eye Hospital.
For those fungal ulcer subjects randomized to the control group, they will receive the standard of care topical treatment for fungal ulcers. This group will have their eyes irrigated with a balanced salt solution.
|
Fungal Ulcer Cross-linking Plus Natamycin
n=26 Participants
Standard of care topical treatment for fungal ulcer with natamycin plus cross-linking
Fungal ulcer cross-linking: Prior to receiving cross-linking, topical amphotericin B or topical natamycin antifungal therapy will be started as per routine at the hospital; a loading dose of amphotericin B or natamycin every 5 minutes x 6 will be followed by dosing every 30 minutes. Amphotericin B and natamycin are routinely used therapies for fungal keratitis at Aravind Eye Hospital.
For those subjects randomized to receive collagen cross-linking, the procedure will be performed as per the routine at the hospital (UV-X machine; strict aseptic precautions; corneal epithelium debrided and 0.1% riboflavin applied for 30 minutes, then UV-A radiation applied for 30 minutes at 370nm with 3mW/cm2). Corneal cross-linking is a routine procedure performed by Aravind Eye Hospital for infectious keratitis.
|
Fungal Ulcer Control With Amphotericin
n=27 Participants
Standard of care topical treatment for fungal ulcer with amphotericin
Fungal ulcer control: Prior to receiving sham cross-linking, topical amphotericin B or topical natamycin antifungal therapy will be started as per routine at the hospital; a loading dose of amphotericin B or natamycin every 5 minutes x 6 will be followed by dosing every 30 minutes. Amphotericin B and natamycin are routinely used therapies for fungal keratitis at Aravind Eye Hospital.
For those fungal ulcer subjects randomized to the control group, they will receive the standard of care topical treatment for fungal ulcers. This group will have their eyes irrigated with a balanced salt solution.
|
Fungal Ulcer Cross-linking Plus Amphotericin
n=26 Participants
Standard of care topical treatment for fungal ulcer with amphotericin plus cross-linking
Fungal ulcer cross-linking: Prior to receiving cross-linking, topical amphotericin B or topical natamycin antifungal therapy will be started as per routine at the hospital; a loading dose of amphotericin B or natamycin every 5 minutes x 6 will be followed by dosing every 30 minutes. Amphotericin B and natamycin are routinely used therapies for fungal keratitis at Aravind Eye Hospital.
For those subjects randomized to receive collagen cross-linking, the procedure will be performed as per the routine at the hospital (UV-X machine; strict aseptic precautions; corneal epithelium debrided and 0.1% riboflavin applied for 30 minutes, then UV-A radiation applied for 30 minutes at 370nm with 3mW/cm2). Corneal cross-linking is a routine procedure performed by Aravind Eye Hospital for infectious keratitis.
|
|---|---|---|---|---|---|---|
|
Microbiological Cure on Repeat Culture
Culture negative
|
5 Participants
|
5 Participants
|
17 Participants
|
14 Participants
|
15 Participants
|
13 Participants
|
|
Microbiological Cure on Repeat Culture
Culture positive
|
14 Participants
|
11 Participants
|
9 Participants
|
12 Participants
|
12 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 3 monthsBest corrected visual acuity will be measured at baseline for both eyes using the standard ETDRS chart light box at the 4- and 1-meter test distances. In the case that the patient reads less than 10 letters at 4 meters, move the patient or the chart to a distance of 1 meter from the patient.
Outcome measures
| Measure |
Bacterial Ulcer Control
n=17 Participants
Standard of care topical treatment for bacterial ulcer
Bacterial ulcer control: For those bacterial ulcer subjects randomized to the control group, they will receive the standard of care topical treatment for bacterial ulcers. This group will have their eyes irrigated with a balanced salt solution.
|
Bacterial Ulcer Cross-linking
n=16 Participants
Standard of care topical treatment for bacterial ulcer plus cross-linking
Bacterial ulcer cross-linking: For those subjects randomized to receive collagen cross-linking, the procedure will be performed as per the routine at the hospital (UV-X machine; strict aseptic precautions; corneal epithelium debrided and 0.1% riboflavin applied for 30 minutes, then UV-A radiation applied for 30 minutes at 370nm with 3mW/cm2). Corneal cross-linking is a routine procedure performed by Aravind Eye Hospital for infectious keratitis.
|
Fungal Ulcer Control With Natamycin
n=21 Participants
Standard of care topical treatment for fungal ulcer with natamycin
Fungal ulcer control: Prior to receiving sham cross-linking, topical amphotericin B or topical natamycin antifungal therapy will be started as per routine at the hospital; a loading dose of amphotericin B or natamycin every 5 minutes x 6 will be followed by dosing every 30 minutes. Amphotericin B and natamycin are routinely used therapies for fungal keratitis at Aravind Eye Hospital.
For those fungal ulcer subjects randomized to the control group, they will receive the standard of care topical treatment for fungal ulcers. This group will have their eyes irrigated with a balanced salt solution.
|
Fungal Ulcer Cross-linking Plus Natamycin
n=27 Participants
Standard of care topical treatment for fungal ulcer with natamycin plus cross-linking
Fungal ulcer cross-linking: Prior to receiving cross-linking, topical amphotericin B or topical natamycin antifungal therapy will be started as per routine at the hospital; a loading dose of amphotericin B or natamycin every 5 minutes x 6 will be followed by dosing every 30 minutes. Amphotericin B and natamycin are routinely used therapies for fungal keratitis at Aravind Eye Hospital.
For those subjects randomized to receive collagen cross-linking, the procedure will be performed as per the routine at the hospital (UV-X machine; strict aseptic precautions; corneal epithelium debrided and 0.1% riboflavin applied for 30 minutes, then UV-A radiation applied for 30 minutes at 370nm with 3mW/cm2). Corneal cross-linking is a routine procedure performed by Aravind Eye Hospital for infectious keratitis.
|
Fungal Ulcer Control With Amphotericin
n=27 Participants
Standard of care topical treatment for fungal ulcer with amphotericin
Fungal ulcer control: Prior to receiving sham cross-linking, topical amphotericin B or topical natamycin antifungal therapy will be started as per routine at the hospital; a loading dose of amphotericin B or natamycin every 5 minutes x 6 will be followed by dosing every 30 minutes. Amphotericin B and natamycin are routinely used therapies for fungal keratitis at Aravind Eye Hospital.
For those fungal ulcer subjects randomized to the control group, they will receive the standard of care topical treatment for fungal ulcers. This group will have their eyes irrigated with a balanced salt solution.
|
Fungal Ulcer Cross-linking Plus Amphotericin
n=25 Participants
Standard of care topical treatment for fungal ulcer with amphotericin plus cross-linking
Fungal ulcer cross-linking: Prior to receiving cross-linking, topical amphotericin B or topical natamycin antifungal therapy will be started as per routine at the hospital; a loading dose of amphotericin B or natamycin every 5 minutes x 6 will be followed by dosing every 30 minutes. Amphotericin B and natamycin are routinely used therapies for fungal keratitis at Aravind Eye Hospital.
For those subjects randomized to receive collagen cross-linking, the procedure will be performed as per the routine at the hospital (UV-X machine; strict aseptic precautions; corneal epithelium debrided and 0.1% riboflavin applied for 30 minutes, then UV-A radiation applied for 30 minutes at 370nm with 3mW/cm2). Corneal cross-linking is a routine procedure performed by Aravind Eye Hospital for infectious keratitis.
|
|---|---|---|---|---|---|---|
|
Best Spectacle-corrected Visual Acuity
|
0.82 logMar
Interval 0.62 to 1.4
|
1.32 logMar
Interval 0.43 to 1.75
|
0.43 logMar
Interval 0.1 to 0.72
|
1 logMar
Interval 0.3 to 1.8
|
0.48 logMar
Interval 0.2 to 1.7
|
0.8 logMar
Interval 0.5 to 1.24
|
SECONDARY outcome
Timeframe: 3 monthsStudy clinician will measure infiltrate or scar size using a standardized protocol with the slit lamp biomicroscope. The geometric mean of the scar size will be measured by recording the horizontal and vertical diameter.
Outcome measures
| Measure |
Bacterial Ulcer Control
n=19 Participants
Standard of care topical treatment for bacterial ulcer
Bacterial ulcer control: For those bacterial ulcer subjects randomized to the control group, they will receive the standard of care topical treatment for bacterial ulcers. This group will have their eyes irrigated with a balanced salt solution.
|
Bacterial Ulcer Cross-linking
n=17 Participants
Standard of care topical treatment for bacterial ulcer plus cross-linking
Bacterial ulcer cross-linking: For those subjects randomized to receive collagen cross-linking, the procedure will be performed as per the routine at the hospital (UV-X machine; strict aseptic precautions; corneal epithelium debrided and 0.1% riboflavin applied for 30 minutes, then UV-A radiation applied for 30 minutes at 370nm with 3mW/cm2). Corneal cross-linking is a routine procedure performed by Aravind Eye Hospital for infectious keratitis.
|
Fungal Ulcer Control With Natamycin
n=26 Participants
Standard of care topical treatment for fungal ulcer with natamycin
Fungal ulcer control: Prior to receiving sham cross-linking, topical amphotericin B or topical natamycin antifungal therapy will be started as per routine at the hospital; a loading dose of amphotericin B or natamycin every 5 minutes x 6 will be followed by dosing every 30 minutes. Amphotericin B and natamycin are routinely used therapies for fungal keratitis at Aravind Eye Hospital.
For those fungal ulcer subjects randomized to the control group, they will receive the standard of care topical treatment for fungal ulcers. This group will have their eyes irrigated with a balanced salt solution.
|
Fungal Ulcer Cross-linking Plus Natamycin
n=27 Participants
Standard of care topical treatment for fungal ulcer with natamycin plus cross-linking
Fungal ulcer cross-linking: Prior to receiving cross-linking, topical amphotericin B or topical natamycin antifungal therapy will be started as per routine at the hospital; a loading dose of amphotericin B or natamycin every 5 minutes x 6 will be followed by dosing every 30 minutes. Amphotericin B and natamycin are routinely used therapies for fungal keratitis at Aravind Eye Hospital.
For those subjects randomized to receive collagen cross-linking, the procedure will be performed as per the routine at the hospital (UV-X machine; strict aseptic precautions; corneal epithelium debrided and 0.1% riboflavin applied for 30 minutes, then UV-A radiation applied for 30 minutes at 370nm with 3mW/cm2). Corneal cross-linking is a routine procedure performed by Aravind Eye Hospital for infectious keratitis.
|
Fungal Ulcer Control With Amphotericin
n=30 Participants
Standard of care topical treatment for fungal ulcer with amphotericin
Fungal ulcer control: Prior to receiving sham cross-linking, topical amphotericin B or topical natamycin antifungal therapy will be started as per routine at the hospital; a loading dose of amphotericin B or natamycin every 5 minutes x 6 will be followed by dosing every 30 minutes. Amphotericin B and natamycin are routinely used therapies for fungal keratitis at Aravind Eye Hospital.
For those fungal ulcer subjects randomized to the control group, they will receive the standard of care topical treatment for fungal ulcers. This group will have their eyes irrigated with a balanced salt solution.
|
Fungal Ulcer Cross-linking Plus Amphotericin
n=28 Participants
Standard of care topical treatment for fungal ulcer with amphotericin plus cross-linking
Fungal ulcer cross-linking: Prior to receiving cross-linking, topical amphotericin B or topical natamycin antifungal therapy will be started as per routine at the hospital; a loading dose of amphotericin B or natamycin every 5 minutes x 6 will be followed by dosing every 30 minutes. Amphotericin B and natamycin are routinely used therapies for fungal keratitis at Aravind Eye Hospital.
For those subjects randomized to receive collagen cross-linking, the procedure will be performed as per the routine at the hospital (UV-X machine; strict aseptic precautions; corneal epithelium debrided and 0.1% riboflavin applied for 30 minutes, then UV-A radiation applied for 30 minutes at 370nm with 3mW/cm2). Corneal cross-linking is a routine procedure performed by Aravind Eye Hospital for infectious keratitis.
|
|---|---|---|---|---|---|---|
|
Scar Size
|
3.5 mm
Interval 2.7 to 4.0
|
3.0 mm
Interval 2.24 to 4.0
|
3.0 mm
Interval 2.5 to 3.5
|
3.9 mm
Interval 2.6 to 4.5
|
3.5 mm
Interval 2.7 to 4.5
|
3.1 mm
Interval 2.8 to 5.0
|
SECONDARY outcome
Timeframe: 3 monthsAdverse events include glaucoma, endophthalmitis, medication reaction, perforation including treatment by therapeutic penetrating keratoplasty.
Outcome measures
| Measure |
Bacterial Ulcer Control
n=19 Participants
Standard of care topical treatment for bacterial ulcer
Bacterial ulcer control: For those bacterial ulcer subjects randomized to the control group, they will receive the standard of care topical treatment for bacterial ulcers. This group will have their eyes irrigated with a balanced salt solution.
|
Bacterial Ulcer Cross-linking
n=17 Participants
Standard of care topical treatment for bacterial ulcer plus cross-linking
Bacterial ulcer cross-linking: For those subjects randomized to receive collagen cross-linking, the procedure will be performed as per the routine at the hospital (UV-X machine; strict aseptic precautions; corneal epithelium debrided and 0.1% riboflavin applied for 30 minutes, then UV-A radiation applied for 30 minutes at 370nm with 3mW/cm2). Corneal cross-linking is a routine procedure performed by Aravind Eye Hospital for infectious keratitis.
|
Fungal Ulcer Control With Natamycin
n=26 Participants
Standard of care topical treatment for fungal ulcer with natamycin
Fungal ulcer control: Prior to receiving sham cross-linking, topical amphotericin B or topical natamycin antifungal therapy will be started as per routine at the hospital; a loading dose of amphotericin B or natamycin every 5 minutes x 6 will be followed by dosing every 30 minutes. Amphotericin B and natamycin are routinely used therapies for fungal keratitis at Aravind Eye Hospital.
For those fungal ulcer subjects randomized to the control group, they will receive the standard of care topical treatment for fungal ulcers. This group will have their eyes irrigated with a balanced salt solution.
|
Fungal Ulcer Cross-linking Plus Natamycin
n=27 Participants
Standard of care topical treatment for fungal ulcer with natamycin plus cross-linking
Fungal ulcer cross-linking: Prior to receiving cross-linking, topical amphotericin B or topical natamycin antifungal therapy will be started as per routine at the hospital; a loading dose of amphotericin B or natamycin every 5 minutes x 6 will be followed by dosing every 30 minutes. Amphotericin B and natamycin are routinely used therapies for fungal keratitis at Aravind Eye Hospital.
For those subjects randomized to receive collagen cross-linking, the procedure will be performed as per the routine at the hospital (UV-X machine; strict aseptic precautions; corneal epithelium debrided and 0.1% riboflavin applied for 30 minutes, then UV-A radiation applied for 30 minutes at 370nm with 3mW/cm2). Corneal cross-linking is a routine procedure performed by Aravind Eye Hospital for infectious keratitis.
|
Fungal Ulcer Control With Amphotericin
n=30 Participants
Standard of care topical treatment for fungal ulcer with amphotericin
Fungal ulcer control: Prior to receiving sham cross-linking, topical amphotericin B or topical natamycin antifungal therapy will be started as per routine at the hospital; a loading dose of amphotericin B or natamycin every 5 minutes x 6 will be followed by dosing every 30 minutes. Amphotericin B and natamycin are routinely used therapies for fungal keratitis at Aravind Eye Hospital.
For those fungal ulcer subjects randomized to the control group, they will receive the standard of care topical treatment for fungal ulcers. This group will have their eyes irrigated with a balanced salt solution.
|
Fungal Ulcer Cross-linking Plus Amphotericin
n=28 Participants
Standard of care topical treatment for fungal ulcer with amphotericin plus cross-linking
Fungal ulcer cross-linking: Prior to receiving cross-linking, topical amphotericin B or topical natamycin antifungal therapy will be started as per routine at the hospital; a loading dose of amphotericin B or natamycin every 5 minutes x 6 will be followed by dosing every 30 minutes. Amphotericin B and natamycin are routinely used therapies for fungal keratitis at Aravind Eye Hospital.
For those subjects randomized to receive collagen cross-linking, the procedure will be performed as per the routine at the hospital (UV-X machine; strict aseptic precautions; corneal epithelium debrided and 0.1% riboflavin applied for 30 minutes, then UV-A radiation applied for 30 minutes at 370nm with 3mW/cm2). Corneal cross-linking is a routine procedure performed by Aravind Eye Hospital for infectious keratitis.
|
|---|---|---|---|---|---|---|
|
Adverse Events Including Rate of Perforation/Need for Therapeutic Penetrating Keratoplasty
Median tarsorrhaphy
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Adverse Events Including Rate of Perforation/Need for Therapeutic Penetrating Keratoplasty
Perforation
|
1 participants
|
0 participants
|
2 participants
|
1 participants
|
4 participants
|
3 participants
|
|
Adverse Events Including Rate of Perforation/Need for Therapeutic Penetrating Keratoplasty
Therapeutic penetrating keratoplasty
|
3 participants
|
1 participants
|
5 participants
|
5 participants
|
5 participants
|
3 participants
|
|
Adverse Events Including Rate of Perforation/Need for Therapeutic Penetrating Keratoplasty
Endophthalmitis
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPopulation: These data were exploratory in nature, we did not collect the data.
Mobility subscale: As measured by the Indian Visual Function Questionnaire (IVFQ) which records quality of life on a scale of 0 to 100 with 100 representing the best quality of life.
Outcome measures
| Measure |
Bacterial Ulcer Control
Standard of care topical treatment for bacterial ulcer
Bacterial ulcer control: For those bacterial ulcer subjects randomized to the control group, they will receive the standard of care topical treatment for bacterial ulcers. This group will have their eyes irrigated with a balanced salt solution.
|
Bacterial Ulcer Cross-linking
Standard of care topical treatment for bacterial ulcer plus cross-linking
Bacterial ulcer cross-linking: For those subjects randomized to receive collagen cross-linking, the procedure will be performed as per the routine at the hospital (UV-X machine; strict aseptic precautions; corneal epithelium debrided and 0.1% riboflavin applied for 30 minutes, then UV-A radiation applied for 30 minutes at 370nm with 3mW/cm2). Corneal cross-linking is a routine procedure performed by Aravind Eye Hospital for infectious keratitis.
|
Fungal Ulcer Control With Natamycin
n=27 Participants
Standard of care topical treatment for fungal ulcer with natamycin
Fungal ulcer control: Prior to receiving sham cross-linking, topical amphotericin B or topical natamycin antifungal therapy will be started as per routine at the hospital; a loading dose of amphotericin B or natamycin every 5 minutes x 6 will be followed by dosing every 30 minutes. Amphotericin B and natamycin are routinely used therapies for fungal keratitis at Aravind Eye Hospital.
For those fungal ulcer subjects randomized to the control group, they will receive the standard of care topical treatment for fungal ulcers. This group will have their eyes irrigated with a balanced salt solution.
|
Fungal Ulcer Cross-linking Plus Natamycin
n=26 Participants
Standard of care topical treatment for fungal ulcer with natamycin plus cross-linking
Fungal ulcer cross-linking: Prior to receiving cross-linking, topical amphotericin B or topical natamycin antifungal therapy will be started as per routine at the hospital; a loading dose of amphotericin B or natamycin every 5 minutes x 6 will be followed by dosing every 30 minutes. Amphotericin B and natamycin are routinely used therapies for fungal keratitis at Aravind Eye Hospital.
For those subjects randomized to receive collagen cross-linking, the procedure will be performed as per the routine at the hospital (UV-X machine; strict aseptic precautions; corneal epithelium debrided and 0.1% riboflavin applied for 30 minutes, then UV-A radiation applied for 30 minutes at 370nm with 3mW/cm2). Corneal cross-linking is a routine procedure performed by Aravind Eye Hospital for infectious keratitis.
|
Fungal Ulcer Control With Amphotericin
n=30 Participants
Standard of care topical treatment for fungal ulcer with amphotericin
Fungal ulcer control: Prior to receiving sham cross-linking, topical amphotericin B or topical natamycin antifungal therapy will be started as per routine at the hospital; a loading dose of amphotericin B or natamycin every 5 minutes x 6 will be followed by dosing every 30 minutes. Amphotericin B and natamycin are routinely used therapies for fungal keratitis at Aravind Eye Hospital.
For those fungal ulcer subjects randomized to the control group, they will receive the standard of care topical treatment for fungal ulcers. This group will have their eyes irrigated with a balanced salt solution.
|
Fungal Ulcer Cross-linking Plus Amphotericin
n=28 Participants
Standard of care topical treatment for fungal ulcer with amphotericin plus cross-linking
Fungal ulcer cross-linking: Prior to receiving cross-linking, topical amphotericin B or topical natamycin antifungal therapy will be started as per routine at the hospital; a loading dose of amphotericin B or natamycin every 5 minutes x 6 will be followed by dosing every 30 minutes. Amphotericin B and natamycin are routinely used therapies for fungal keratitis at Aravind Eye Hospital.
For those subjects randomized to receive collagen cross-linking, the procedure will be performed as per the routine at the hospital (UV-X machine; strict aseptic precautions; corneal epithelium debrided and 0.1% riboflavin applied for 30 minutes, then UV-A radiation applied for 30 minutes at 370nm with 3mW/cm2). Corneal cross-linking is a routine procedure performed by Aravind Eye Hospital for infectious keratitis.
|
|---|---|---|---|---|---|---|
|
Vision Related Quality of Life
|
—
|
—
|
89.6 score on a scale
Interval 71.9 to 100.0
|
91.7 score on a scale
Interval 75.0 to 100.0
|
95.8 score on a scale
Interval 72.9 to 100.0
|
89.6 score on a scale
Interval 71.9 to 100.0
|
Adverse Events
Bacterial Ulcer Control
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Bacterial Ulcer Cross-linking
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Fungal Ulcer Control With Natamycin
Serious events: 7 serious events
Other events: 0 other events
Deaths: 0 deaths
Fungal Ulcer Cross-linking Plus Natamycin
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Fungal Ulcer Control With Amphotericin
Serious events: 10 serious events
Other events: 0 other events
Deaths: 0 deaths
Fungal Ulcer Cross-linking Plus Amphotericin
Serious events: 6 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bacterial Ulcer Control
n=19 participants at risk
Standard of care topical treatment for bacterial ulcer
Bacterial ulcer control: For those bacterial ulcer subjects randomized to the control group, they will receive the standard of care topical treatment for bacterial ulcers. This group will have their eyes irrigated with a balanced salt solution.
|
Bacterial Ulcer Cross-linking
n=17 participants at risk
Standard of care topical treatment for bacterial ulcer plus cross-linking
Bacterial ulcer cross-linking: For those subjects randomized to receive collagen cross-linking, the procedure will be performed as per the routine at the hospital (UV-X machine; strict aseptic precautions; corneal epithelium debrided and 0.1% riboflavin applied for 30 minutes, then UV-A radiation applied for 30 minutes at 370nm with 3mW/cm2). Corneal cross-linking is a routine procedure performed by Aravind Eye Hospital for infectious keratitis.
|
Fungal Ulcer Control With Natamycin
n=26 participants at risk
Standard of care topical treatment for fungal ulcer with natamycin
Fungal ulcer control: Prior to receiving sham cross-linking, topical amphotericin B or topical natamycin antifungal therapy will be started as per routine at the hospital; a loading dose of amphotericin B or natamycin every 5 minutes x 6 will be followed by dosing every 30 minutes. Amphotericin B and natamycin are routinely used therapies for fungal keratitis at Aravind Eye Hospital.
For those fungal ulcer subjects randomized to the control group, they will receive the standard of care topical treatment for fungal ulcers. This group will have their eyes irrigated with a balanced salt solution.
|
Fungal Ulcer Cross-linking Plus Natamycin
n=27 participants at risk
Standard of care topical treatment for fungal ulcer with natamycin plus cross-linking
Fungal ulcer cross-linking: Prior to receiving cross-linking, topical amphotericin B or topical natamycin antifungal therapy will be started as per routine at the hospital; a loading dose of amphotericin B or natamycin every 5 minutes x 6 will be followed by dosing every 30 minutes. Amphotericin B and natamycin are routinely used therapies for fungal keratitis at Aravind Eye Hospital.
For those subjects randomized to receive collagen cross-linking, the procedure will be performed as per the routine at the hospital (UV-X machine; strict aseptic precautions; corneal epithelium debrided and 0.1% riboflavin applied for 30 minutes, then UV-A radiation applied for 30 minutes at 370nm with 3mW/cm2). Corneal cross-linking is a routine procedure performed by Aravind Eye Hospital for infectious keratitis.
|
Fungal Ulcer Control With Amphotericin
n=30 participants at risk
Standard of care topical treatment for fungal ulcer with amphotericin
Fungal ulcer control: Prior to receiving sham cross-linking, topical amphotericin B or topical natamycin antifungal therapy will be started as per routine at the hospital; a loading dose of amphotericin B or natamycin every 5 minutes x 6 will be followed by dosing every 30 minutes. Amphotericin B and natamycin are routinely used therapies for fungal keratitis at Aravind Eye Hospital.
For those fungal ulcer subjects randomized to the control group, they will receive the standard of care topical treatment for fungal ulcers. This group will have their eyes irrigated with a balanced salt solution.
|
Fungal Ulcer Cross-linking Plus Amphotericin
n=28 participants at risk
Standard of care topical treatment for fungal ulcer with amphotericin plus cross-linking
Fungal ulcer cross-linking: Prior to receiving cross-linking, topical amphotericin B or topical natamycin antifungal therapy will be started as per routine at the hospital; a loading dose of amphotericin B or natamycin every 5 minutes x 6 will be followed by dosing every 30 minutes. Amphotericin B and natamycin are routinely used therapies for fungal keratitis at Aravind Eye Hospital.
For those subjects randomized to receive collagen cross-linking, the procedure will be performed as per the routine at the hospital (UV-X machine; strict aseptic precautions; corneal epithelium debrided and 0.1% riboflavin applied for 30 minutes, then UV-A radiation applied for 30 minutes at 370nm with 3mW/cm2). Corneal cross-linking is a routine procedure performed by Aravind Eye Hospital for infectious keratitis.
|
|---|---|---|---|---|---|---|
|
Eye disorders
Perforation
|
5.3%
1/19 • 3 months
Adverse events were systematically assessed at every study visit.
|
0.00%
0/17 • 3 months
Adverse events were systematically assessed at every study visit.
|
7.7%
2/26 • 3 months
Adverse events were systematically assessed at every study visit.
|
3.7%
1/27 • 3 months
Adverse events were systematically assessed at every study visit.
|
13.3%
4/30 • 3 months
Adverse events were systematically assessed at every study visit.
|
10.7%
3/28 • 3 months
Adverse events were systematically assessed at every study visit.
|
|
Eye disorders
Therapeutic penetrating keratoplasty
|
15.8%
3/19 • 3 months
Adverse events were systematically assessed at every study visit.
|
5.9%
1/17 • 3 months
Adverse events were systematically assessed at every study visit.
|
19.2%
5/26 • 3 months
Adverse events were systematically assessed at every study visit.
|
18.5%
5/27 • 3 months
Adverse events were systematically assessed at every study visit.
|
16.7%
5/30 • 3 months
Adverse events were systematically assessed at every study visit.
|
10.7%
3/28 • 3 months
Adverse events were systematically assessed at every study visit.
|
|
Eye disorders
Endophthalmitis
|
0.00%
0/19 • 3 months
Adverse events were systematically assessed at every study visit.
|
0.00%
0/17 • 3 months
Adverse events were systematically assessed at every study visit.
|
0.00%
0/26 • 3 months
Adverse events were systematically assessed at every study visit.
|
0.00%
0/27 • 3 months
Adverse events were systematically assessed at every study visit.
|
3.3%
1/30 • 3 months
Adverse events were systematically assessed at every study visit.
|
0.00%
0/28 • 3 months
Adverse events were systematically assessed at every study visit.
|
Other adverse events
| Measure |
Bacterial Ulcer Control
n=19 participants at risk
Standard of care topical treatment for bacterial ulcer
Bacterial ulcer control: For those bacterial ulcer subjects randomized to the control group, they will receive the standard of care topical treatment for bacterial ulcers. This group will have their eyes irrigated with a balanced salt solution.
|
Bacterial Ulcer Cross-linking
n=17 participants at risk
Standard of care topical treatment for bacterial ulcer plus cross-linking
Bacterial ulcer cross-linking: For those subjects randomized to receive collagen cross-linking, the procedure will be performed as per the routine at the hospital (UV-X machine; strict aseptic precautions; corneal epithelium debrided and 0.1% riboflavin applied for 30 minutes, then UV-A radiation applied for 30 minutes at 370nm with 3mW/cm2). Corneal cross-linking is a routine procedure performed by Aravind Eye Hospital for infectious keratitis.
|
Fungal Ulcer Control With Natamycin
n=26 participants at risk
Standard of care topical treatment for fungal ulcer with natamycin
Fungal ulcer control: Prior to receiving sham cross-linking, topical amphotericin B or topical natamycin antifungal therapy will be started as per routine at the hospital; a loading dose of amphotericin B or natamycin every 5 minutes x 6 will be followed by dosing every 30 minutes. Amphotericin B and natamycin are routinely used therapies for fungal keratitis at Aravind Eye Hospital.
For those fungal ulcer subjects randomized to the control group, they will receive the standard of care topical treatment for fungal ulcers. This group will have their eyes irrigated with a balanced salt solution.
|
Fungal Ulcer Cross-linking Plus Natamycin
n=27 participants at risk
Standard of care topical treatment for fungal ulcer with natamycin plus cross-linking
Fungal ulcer cross-linking: Prior to receiving cross-linking, topical amphotericin B or topical natamycin antifungal therapy will be started as per routine at the hospital; a loading dose of amphotericin B or natamycin every 5 minutes x 6 will be followed by dosing every 30 minutes. Amphotericin B and natamycin are routinely used therapies for fungal keratitis at Aravind Eye Hospital.
For those subjects randomized to receive collagen cross-linking, the procedure will be performed as per the routine at the hospital (UV-X machine; strict aseptic precautions; corneal epithelium debrided and 0.1% riboflavin applied for 30 minutes, then UV-A radiation applied for 30 minutes at 370nm with 3mW/cm2). Corneal cross-linking is a routine procedure performed by Aravind Eye Hospital for infectious keratitis.
|
Fungal Ulcer Control With Amphotericin
n=30 participants at risk
Standard of care topical treatment for fungal ulcer with amphotericin
Fungal ulcer control: Prior to receiving sham cross-linking, topical amphotericin B or topical natamycin antifungal therapy will be started as per routine at the hospital; a loading dose of amphotericin B or natamycin every 5 minutes x 6 will be followed by dosing every 30 minutes. Amphotericin B and natamycin are routinely used therapies for fungal keratitis at Aravind Eye Hospital.
For those fungal ulcer subjects randomized to the control group, they will receive the standard of care topical treatment for fungal ulcers. This group will have their eyes irrigated with a balanced salt solution.
|
Fungal Ulcer Cross-linking Plus Amphotericin
n=28 participants at risk
Standard of care topical treatment for fungal ulcer with amphotericin plus cross-linking
Fungal ulcer cross-linking: Prior to receiving cross-linking, topical amphotericin B or topical natamycin antifungal therapy will be started as per routine at the hospital; a loading dose of amphotericin B or natamycin every 5 minutes x 6 will be followed by dosing every 30 minutes. Amphotericin B and natamycin are routinely used therapies for fungal keratitis at Aravind Eye Hospital.
For those subjects randomized to receive collagen cross-linking, the procedure will be performed as per the routine at the hospital (UV-X machine; strict aseptic precautions; corneal epithelium debrided and 0.1% riboflavin applied for 30 minutes, then UV-A radiation applied for 30 minutes at 370nm with 3mW/cm2). Corneal cross-linking is a routine procedure performed by Aravind Eye Hospital for infectious keratitis.
|
|---|---|---|---|---|---|---|
|
Eye disorders
Median tarsorrhaphy
|
0.00%
0/19 • 3 months
Adverse events were systematically assessed at every study visit.
|
0.00%
0/17 • 3 months
Adverse events were systematically assessed at every study visit.
|
0.00%
0/26 • 3 months
Adverse events were systematically assessed at every study visit.
|
0.00%
0/27 • 3 months
Adverse events were systematically assessed at every study visit.
|
0.00%
0/30 • 3 months
Adverse events were systematically assessed at every study visit.
|
3.6%
1/28 • 3 months
Adverse events were systematically assessed at every study visit.
|
Additional Information
Sarah Abedelrahman, Research Data Analyst
UCSF, Proctor Foundation
Phone: 2135093817
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place