Trial Outcomes & Findings for Effects of Cataract Extraction Surgery and Limbal Relaxing Incision on Corneal Sensation and Dry Eye (NCT NCT01161771)
NCT ID: NCT01161771
Last Updated: 2012-07-26
Results Overview
The percentage of subjects at month 3 with corneal sensitivity \< 50 mm at any of the locations measured. Corneal sensitivity is evaluated by using a nylon filament to measure the capability of the cornea (clear front portion of the eye) to respond to touch. The longest filament length at which a minimum of the 3 out of 5 stimulus applications produce a positive response from the subject was the corneal touch threshold (sensitivity). Measurements were taken at 5 different locations in each cornea.
COMPLETED
32 participants
Month 3
2012-07-26
Participant Flow
Participant milestones
| Measure |
Patients With Cataract and Corneal Astigmatism
Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Cataract Extraction Surgery and Limbal Relaxing Incision on Corneal Sensation and Dry Eye
Baseline characteristics by cohort
| Measure |
Patients With Cataract and Corneal Astigmatism
n=32 Participants
Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
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|---|---|
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Age Continuous
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68.29 years
n=5 Participants
|
|
Sex: Female, Male
Female
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21 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 3Population: Subjects enrolled who met the inclusion criteria of having 2 limbal relaxing incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.
The percentage of subjects at month 3 with corneal sensitivity \< 50 mm at any of the locations measured. Corneal sensitivity is evaluated by using a nylon filament to measure the capability of the cornea (clear front portion of the eye) to respond to touch. The longest filament length at which a minimum of the 3 out of 5 stimulus applications produce a positive response from the subject was the corneal touch threshold (sensitivity). Measurements were taken at 5 different locations in each cornea.
Outcome measures
| Measure |
Patients With Cataract and Corneal Astigmatism
n=23 Participants
Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
|
|---|---|
|
The Percentage of Subjects at Month 3 With Corneal Sensitivity < 50 Millimeters (mm) at Any of the Locations Measured
Area 1 (Center) at Month 3
|
13 Percentage of Subjects
|
|
The Percentage of Subjects at Month 3 With Corneal Sensitivity < 50 Millimeters (mm) at Any of the Locations Measured
Area 2 (Center of LRI 1) at Month 3
|
13 Percentage of Subjects
|
|
The Percentage of Subjects at Month 3 With Corneal Sensitivity < 50 Millimeters (mm) at Any of the Locations Measured
Area 3 (Center of LRI 2) at Month 3
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21.7 Percentage of Subjects
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|
The Percentage of Subjects at Month 3 With Corneal Sensitivity < 50 Millimeters (mm) at Any of the Locations Measured
Area 4 (90 degrees from LRI 1) at Month 3
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13 Percentage of Subjects
|
|
The Percentage of Subjects at Month 3 With Corneal Sensitivity < 50 Millimeters (mm) at Any of the Locations Measured
Area 5 (90 degrees from LRI 2) at Month 3
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8.7 Percentage of Subjects
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SECONDARY outcome
Timeframe: Baseline, Month 3Population: Subjects enrolled who met the inclusion criteria of having 2 limbal relaxing incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.
Change from baseline in OSDI total score at month 3. The OSDI is a 12-question survey for subjects to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4 = all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.
Outcome measures
| Measure |
Patients With Cataract and Corneal Astigmatism
n=23 Participants
Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
|
|---|---|
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Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score at Month 3
Baseline
|
15.739 Scores on a Scale
Standard Deviation 8.368
|
|
Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score at Month 3
Change from Baseline at Month 3
|
-9.826 Scores on a Scale
Standard Deviation 7.912
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: Subjects enrolled who met the inclusion criteria of having 2 limbal relaxing incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.
Change from baseline in corneal staining at month 3. The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining following administration of fluorescein dye in the eye is graded using a 6-point scale (0= no staining, 5 = severe staining) over 5 areas of the clear central part of the eye for a minimum score of 0 and a maximum score of 25. The higher the grade score, the worse the dry eye condition. A positive number change from baseline represents an increase in corneal staining (worsening of dry eye).
Outcome measures
| Measure |
Patients With Cataract and Corneal Astigmatism
n=23 Participants
Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
|
|---|---|
|
Change From Baseline in Corneal Staining at Month 3
Baseline
|
0.652 Scores on a Scale
Standard Deviation 1.668
|
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Change From Baseline in Corneal Staining at Month 3
Change from Baseline at Month 3
|
0.261 Scores on a Scale
Standard Deviation 2.158
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SECONDARY outcome
Timeframe: Baseline, Month 3Population: Subjects enrolled who met the inclusion criteria of having 2 limbal incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.
Change from baseline in conjunctival staining severity score at month 3. The conjunctiva is the clear membrane covering the white surface of the eye. Conjunctival staining following ocular administration of lissamine green dye was graded using a 6-point scale (0= no staining, 5= severe staining) over 6 areas of the white part of the eye for a minimum score of 0 and a maximum score of 30. The higher the score, the worse the dry eye condition. A negative number change from baseline represents a decrease in the severity of conjunctival staining (improvement)
Outcome measures
| Measure |
Patients With Cataract and Corneal Astigmatism
n=23 Participants
Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
|
|---|---|
|
Change From Baseline in Conjunctival Staining at Month 3
Baseline
|
1.087 Scores on a Scale
Standard Deviation 2.557
|
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Change From Baseline in Conjunctival Staining at Month 3
Change from Baseline at Month 3
|
-0.174 Scores on a Scale
Standard Deviation 2.949
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SECONDARY outcome
Timeframe: Baseline, Month 3Population: Subjects enrolled who met the inclusion criteria of having 2 limbal relaxing incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.
Change from baseline in tear break-up time (TBUT) at month 3. TBUT is the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A negative number change from baseline indicates a decrease in TBUT (worsening).
Outcome measures
| Measure |
Patients With Cataract and Corneal Astigmatism
n=23 Participants
Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
|
|---|---|
|
Change From Baseline in Tear Break-Up Time at Month 3
Baseline
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16.4 Seconds
Standard Deviation 12.5
|
|
Change From Baseline in Tear Break-Up Time at Month 3
Change from Baseline at Month 3
|
-3.71 Seconds
Standard Deviation NA
Mean calculated without standard deviation. No other measure of dispersion was calculated.
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: Subjects enrolled who met the inclusion criteria of having 2 limbal relaxing incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.
Change from baseline in Schirmer's Test result at month 3. The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. A positive number change from baseline indicates an increase in tears (improvement).
Outcome measures
| Measure |
Patients With Cataract and Corneal Astigmatism
n=23 Participants
Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
|
|---|---|
|
Change From Baseline in Schirmer's Test at Month 3
Baseline
|
11.091 Millimeters of Tears
Standard Deviation 5.163
|
|
Change From Baseline in Schirmer's Test at Month 3
Change from Baseline at Month 3
|
0.909 Millimeters of Tears
Standard Deviation 5.74
|
Adverse Events
Patients With Cataract and Corneal Astigmatism
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
- Publication restrictions are in place
Restriction type: OTHER