Trial Outcomes & Findings for Micropulse for Suppression of Diabetic Macular Edema (NCT NCT03519581)
NCT ID: NCT03519581
Last Updated: 2024-12-17
Results Overview
BCVA measured using ETDRS testing. The study endpoint was reached if the study patient experienced vision loss of ≥10 letters (≥2 lines) at any visit or 5-9 letters (1-2 lines) at 2 consecutive visits ≤28 days apart, based on the criteria for initiating anti-VEGF therapy as defined in the DRCR Protocol V study.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
6 months
Results posted on
2024-12-17
Participant Flow
Unit of analysis: Eyes
Participant milestones
| Measure |
Micropulse Laser Treatment
Eyes assigned to the micropulse laser arm of the trial will undergo the following procedures:
1. Confirmation of the subject's identity and eye to be treated
2. Subject's eye will be dilated
3. Subject will be positioned at the slit lamp for treatment
4. Application of subthreshold micropulse laser using the Iridex IQ577 laser unit. (intermittent pulsed energy) in a 7 X 7 grid pattern surrounding the fovea.
Micropulse Laser Treatment: Participant's study eye will be dilated prior to being comfortably seated at the slit lamp for treatment. Application of micropulse laser on retinal surface will occur using TxCell Scanning Delivery System in a 7 x 7 grid to surround the fovea.
|
Sham Treatment
Eyes assigned to the sham arm of the trial will undergo the following procedures:
1. Confirmation of the subject's identity and eye to be treated
2. Subject's eye will be dilated
3. Subject will be positioned at the slit lamp for treatment
4. No Actual laser treatment will occur
Sham Treatment: Participant's study eye will be dilated prior to being comfortably seated at the slit lamp for treatment. No actual laser treatment will occur.
|
|---|---|---|
|
Overall Study
STARTED
|
16 16
|
11 11
|
|
Overall Study
COMPLETED
|
2 2
|
2 2
|
|
Overall Study
NOT COMPLETED
|
14 14
|
9 9
|
Reasons for withdrawal
| Measure |
Micropulse Laser Treatment
Eyes assigned to the micropulse laser arm of the trial will undergo the following procedures:
1. Confirmation of the subject's identity and eye to be treated
2. Subject's eye will be dilated
3. Subject will be positioned at the slit lamp for treatment
4. Application of subthreshold micropulse laser using the Iridex IQ577 laser unit. (intermittent pulsed energy) in a 7 X 7 grid pattern surrounding the fovea.
Micropulse Laser Treatment: Participant's study eye will be dilated prior to being comfortably seated at the slit lamp for treatment. Application of micropulse laser on retinal surface will occur using TxCell Scanning Delivery System in a 7 x 7 grid to surround the fovea.
|
Sham Treatment
Eyes assigned to the sham arm of the trial will undergo the following procedures:
1. Confirmation of the subject's identity and eye to be treated
2. Subject's eye will be dilated
3. Subject will be positioned at the slit lamp for treatment
4. No Actual laser treatment will occur
Sham Treatment: Participant's study eye will be dilated prior to being comfortably seated at the slit lamp for treatment. No actual laser treatment will occur.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
|
Overall Study
Adverse Event
|
5
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Change to insurance
|
2
|
1
|
|
Overall Study
Other
|
2
|
4
|
Baseline Characteristics
19 participants were enrolled. Of those 19 participants, 11 had only one eye enrolled. This accounts for the row population difference.
Baseline characteristics by cohort
| Measure |
Micropulse Laser Treatment
n=16 Eyes
Subjects assigned to the micropulse laser arm of the trial will undergo the following procedures:
1. Confirmation of the subject's identity and eye to be treated
2. Subject's eye will be dilated
3. Subject will be positioned at the slit lamp for treatment
4. Application of subthreshold micropulse laser using the Iridex IQ577 laser unit. (intermittent pulsed energy) in a 7 X 7 grid pattern surrounding the fovea.
Micropulse Laser Treatment: Participant's study eye will be dilated prior to being comfortably seated at the slit lamp for treatment. Application of micropulse laser on retinal surface will occur using TxCell Scanning Delivery System in a 7 x 7 grid to surround the fovea.
|
Sham Treatment
n=11 Eyes
Subjects assigned to the sham arm of the trial will undergo the following procedures:
1. Confirmation of the subject's identity and eye to be treated
2. Subject's eye will be dilated
3. Subject will be positioned at the slit lamp for treatment
4. No Actual laser treatment will occur
Sham Treatment: Participant's study eye will be dilated prior to being comfortably seated at the slit lamp for treatment. No actual laser treatment will occur.
|
Total
n=27 Eyes
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.1 Years
STANDARD_DEVIATION 8.4 • n=14 Eyes • 19 participants were enrolled. Of those 19 participants, 11 had only one eye enrolled. This accounts for the row population difference.
|
54.9 Years
STANDARD_DEVIATION 10.9 • n=23 Eyes • 19 participants were enrolled. Of those 19 participants, 11 had only one eye enrolled. This accounts for the row population difference.
|
56.2 Years
STANDARD_DEVIATION 9.3 • n=50 Eyes • 19 participants were enrolled. Of those 19 participants, 11 had only one eye enrolled. This accounts for the row population difference.
|
|
Sex: Female, Male
Female
|
6 Eyes
n=14 Eyes
|
4 Eyes
n=23 Eyes
|
10 Eyes
n=50 Eyes
|
|
Sex: Female, Male
Male
|
10 Eyes
n=14 Eyes
|
7 Eyes
n=23 Eyes
|
17 Eyes
n=50 Eyes
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Eyes
n=14 Eyes
|
0 Eyes
n=23 Eyes
|
0 Eyes
n=50 Eyes
|
|
Race (NIH/OMB)
Asian
|
0 Eyes
n=14 Eyes
|
0 Eyes
n=23 Eyes
|
0 Eyes
n=50 Eyes
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Eyes
n=14 Eyes
|
1 Eyes
n=23 Eyes
|
1 Eyes
n=50 Eyes
|
|
Race (NIH/OMB)
Black or African American
|
8 Eyes
n=14 Eyes
|
4 Eyes
n=23 Eyes
|
12 Eyes
n=50 Eyes
|
|
Race (NIH/OMB)
White
|
8 Eyes
n=14 Eyes
|
6 Eyes
n=23 Eyes
|
14 Eyes
n=50 Eyes
|
|
Race (NIH/OMB)
More than one race
|
0 Eyes
n=14 Eyes
|
0 Eyes
n=23 Eyes
|
0 Eyes
n=50 Eyes
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Eyes
n=14 Eyes
|
0 Eyes
n=23 Eyes
|
0 Eyes
n=50 Eyes
|
|
Best Corrected Visual Acuity (BCVA)
|
81.8 ETDRS Letters Read
STANDARD_DEVIATION 5.0 • n=14 Eyes
|
82.5 ETDRS Letters Read
STANDARD_DEVIATION 4.0 • n=23 Eyes
|
82.1 ETDRS Letters Read
STANDARD_DEVIATION 4.5 • n=50 Eyes
|
|
Low Luminance Visual Acuity (LLVA)
|
38.8 EDTDRS Letters Read
STANDARD_DEVIATION 7.5 • n=14 Eyes
|
40.6 EDTDRS Letters Read
STANDARD_DEVIATION 7.61 • n=23 Eyes
|
39.5 EDTDRS Letters Read
STANDARD_DEVIATION 7.5 • n=50 Eyes
|
|
Contrast Sensitivity (CS)
|
1.58 unit less
STANDARD_DEVIATION 0.16 • n=14 Eyes
|
1.61 unit less
STANDARD_DEVIATION 0.17 • n=23 Eyes
|
1.59 unit less
STANDARD_DEVIATION 0.16 • n=50 Eyes
|
|
Central Subfield Thickness (CST)
|
329.7 microns
STANDARD_DEVIATION 23.9 • n=14 Eyes
|
354.9 microns
STANDARD_DEVIATION 76.6 • n=23 Eyes
|
340.0 microns
STANDARD_DEVIATION 52.4 • n=50 Eyes
|
|
Microperimetry Average Threshold
|
24.8 decibels (dB)
STANDARD_DEVIATION 1.9 • n=14 Eyes
|
24.5 decibels (dB)
STANDARD_DEVIATION 2.1 • n=23 Eyes
|
24.6 decibels (dB)
STANDARD_DEVIATION 2.0 • n=50 Eyes
|
PRIMARY outcome
Timeframe: 6 monthsBCVA measured using ETDRS testing. The study endpoint was reached if the study patient experienced vision loss of ≥10 letters (≥2 lines) at any visit or 5-9 letters (1-2 lines) at 2 consecutive visits ≤28 days apart, based on the criteria for initiating anti-VEGF therapy as defined in the DRCR Protocol V study.
Outcome measures
| Measure |
Micropulse Laser Treatment
n=16 Eyes
Eyes assigned to the micropulse laser arm of the trial will undergo the following procedures:
1. Confirmation of the subject's identity and eye to be treated
2. Subject's eye will be dilated
3. Subject will be positioned at the slit lamp for treatment
4. Application of subthreshold micropulse laser using the Iridex IQ577 laser unit. (intermittent pulsed energy) in a 7 X 7 grid pattern surrounding the fovea.
Micropulse Laser Treatment: Participant's study eye will be dilated prior to being comfortably seated at the slit lamp for treatment. Application of micropulse laser on retinal surface will occur using TxCell Scanning Delivery System in a 7 x 7 grid to surround the fovea.
|
Sham Treatment
n=11 Eyes
Eyes assigned to the sham arm of the trial will undergo the following procedures:
1. Confirmation of the subject's identity and eye to be treated
2. Subject's eye will be dilated
3. Subject will be positioned at the slit lamp for treatment
4. No Actual laser treatment will occur
Sham Treatment: Participant's study eye will be dilated prior to being comfortably seated at the slit lamp for treatment. No actual laser treatment will occur.
|
|---|---|---|
|
Percentage of Subjects With Vision Loss to 20/40 or Worse
|
5 Eyes
|
3 Eyes
|
SECONDARY outcome
Timeframe: 6 monthsVisual acuity measured using ETDRS
Outcome measures
| Measure |
Micropulse Laser Treatment
n=16 Eyes
Eyes assigned to the micropulse laser arm of the trial will undergo the following procedures:
1. Confirmation of the subject's identity and eye to be treated
2. Subject's eye will be dilated
3. Subject will be positioned at the slit lamp for treatment
4. Application of subthreshold micropulse laser using the Iridex IQ577 laser unit. (intermittent pulsed energy) in a 7 X 7 grid pattern surrounding the fovea.
Micropulse Laser Treatment: Participant's study eye will be dilated prior to being comfortably seated at the slit lamp for treatment. Application of micropulse laser on retinal surface will occur using TxCell Scanning Delivery System in a 7 x 7 grid to surround the fovea.
|
Sham Treatment
n=11 Eyes
Eyes assigned to the sham arm of the trial will undergo the following procedures:
1. Confirmation of the subject's identity and eye to be treated
2. Subject's eye will be dilated
3. Subject will be positioned at the slit lamp for treatment
4. No Actual laser treatment will occur
Sham Treatment: Participant's study eye will be dilated prior to being comfortably seated at the slit lamp for treatment. No actual laser treatment will occur.
|
|---|---|---|
|
Visual Acuity at 6 Month
|
79.4 Letters Read
Standard Deviation 8.0
|
83.9 Letters Read
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: 6 monthsLow Luminance Visual acuity measured with a 2.0-log unit neutral density filter
Outcome measures
| Measure |
Micropulse Laser Treatment
n=16 Eyes
Eyes assigned to the micropulse laser arm of the trial will undergo the following procedures:
1. Confirmation of the subject's identity and eye to be treated
2. Subject's eye will be dilated
3. Subject will be positioned at the slit lamp for treatment
4. Application of subthreshold micropulse laser using the Iridex IQ577 laser unit. (intermittent pulsed energy) in a 7 X 7 grid pattern surrounding the fovea.
Micropulse Laser Treatment: Participant's study eye will be dilated prior to being comfortably seated at the slit lamp for treatment. Application of micropulse laser on retinal surface will occur using TxCell Scanning Delivery System in a 7 x 7 grid to surround the fovea.
|
Sham Treatment
n=11 Eyes
Eyes assigned to the sham arm of the trial will undergo the following procedures:
1. Confirmation of the subject's identity and eye to be treated
2. Subject's eye will be dilated
3. Subject will be positioned at the slit lamp for treatment
4. No Actual laser treatment will occur
Sham Treatment: Participant's study eye will be dilated prior to being comfortably seated at the slit lamp for treatment. No actual laser treatment will occur.
|
|---|---|---|
|
Low Luminance Visual Acuity at 6 Months
|
30.7 Letters Read
Standard Deviation 13.5
|
40.1 Letters Read
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: 6 monthsContrast sensitivity is measured using a single, large letter size (20/60 optotype) with contrast varying across groups of letters. The contrast sensitivity chart (CS) uses letters whose contrast varies from high to low. The scale is 0.0 (minimum) to 2.0 (maximum). A higher score equates to a better outcome. The score is based on the contrast of the last group in which 2 or 3 letters were correctly read. A score of 2.0 indicates normal CS of 100%. Scores \< than 2.0 signify poorer CS; scores \< than 1.5 is consistent with visual impairment; a score \< than 1.0 represents visual disability.
Outcome measures
| Measure |
Micropulse Laser Treatment
n=16 Eyes
Eyes assigned to the micropulse laser arm of the trial will undergo the following procedures:
1. Confirmation of the subject's identity and eye to be treated
2. Subject's eye will be dilated
3. Subject will be positioned at the slit lamp for treatment
4. Application of subthreshold micropulse laser using the Iridex IQ577 laser unit. (intermittent pulsed energy) in a 7 X 7 grid pattern surrounding the fovea.
Micropulse Laser Treatment: Participant's study eye will be dilated prior to being comfortably seated at the slit lamp for treatment. Application of micropulse laser on retinal surface will occur using TxCell Scanning Delivery System in a 7 x 7 grid to surround the fovea.
|
Sham Treatment
n=11 Eyes
Eyes assigned to the sham arm of the trial will undergo the following procedures:
1. Confirmation of the subject's identity and eye to be treated
2. Subject's eye will be dilated
3. Subject will be positioned at the slit lamp for treatment
4. No Actual laser treatment will occur
Sham Treatment: Participant's study eye will be dilated prior to being comfortably seated at the slit lamp for treatment. No actual laser treatment will occur.
|
|---|---|---|
|
Contrast Sensitivity at 6 Months
|
1.54 unit less
Standard Deviation .21
|
1.61 unit less
Standard Deviation .23
|
SECONDARY outcome
Timeframe: 6 monthsUsing Heidelberg Spectralis device to measure central subfield thickness (CST)
Outcome measures
| Measure |
Micropulse Laser Treatment
n=16 Eyes
Eyes assigned to the micropulse laser arm of the trial will undergo the following procedures:
1. Confirmation of the subject's identity and eye to be treated
2. Subject's eye will be dilated
3. Subject will be positioned at the slit lamp for treatment
4. Application of subthreshold micropulse laser using the Iridex IQ577 laser unit. (intermittent pulsed energy) in a 7 X 7 grid pattern surrounding the fovea.
Micropulse Laser Treatment: Participant's study eye will be dilated prior to being comfortably seated at the slit lamp for treatment. Application of micropulse laser on retinal surface will occur using TxCell Scanning Delivery System in a 7 x 7 grid to surround the fovea.
|
Sham Treatment
n=11 Eyes
Eyes assigned to the sham arm of the trial will undergo the following procedures:
1. Confirmation of the subject's identity and eye to be treated
2. Subject's eye will be dilated
3. Subject will be positioned at the slit lamp for treatment
4. No Actual laser treatment will occur
Sham Treatment: Participant's study eye will be dilated prior to being comfortably seated at the slit lamp for treatment. No actual laser treatment will occur.
|
|---|---|---|
|
Central Subfield Thickness (CST) at 6 Months
|
357.8 microns
Standard Deviation 90.4
|
356.9 microns
Standard Deviation 50.0
|
SECONDARY outcome
Timeframe: 6 monthsPerformed using the Macular Integrity Assessment (MAIA) Instrument
Outcome measures
| Measure |
Micropulse Laser Treatment
n=16 Eyes
Eyes assigned to the micropulse laser arm of the trial will undergo the following procedures:
1. Confirmation of the subject's identity and eye to be treated
2. Subject's eye will be dilated
3. Subject will be positioned at the slit lamp for treatment
4. Application of subthreshold micropulse laser using the Iridex IQ577 laser unit. (intermittent pulsed energy) in a 7 X 7 grid pattern surrounding the fovea.
Micropulse Laser Treatment: Participant's study eye will be dilated prior to being comfortably seated at the slit lamp for treatment. Application of micropulse laser on retinal surface will occur using TxCell Scanning Delivery System in a 7 x 7 grid to surround the fovea.
|
Sham Treatment
n=11 Eyes
Eyes assigned to the sham arm of the trial will undergo the following procedures:
1. Confirmation of the subject's identity and eye to be treated
2. Subject's eye will be dilated
3. Subject will be positioned at the slit lamp for treatment
4. No Actual laser treatment will occur
Sham Treatment: Participant's study eye will be dilated prior to being comfortably seated at the slit lamp for treatment. No actual laser treatment will occur.
|
|---|---|---|
|
Microperimetry Average Threshold at 6 Month
|
22.5 dB
Standard Deviation 3.9
|
24.4 dB
Standard Deviation 3.9
|
Adverse Events
Micropulse Laser Treatment
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Sham Treatment
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Micropulse Laser Treatment
n=16 participants at risk
Eyes assigned to the micropulse laser arm of the trial will undergo the following procedures:
1. Confirmation of the subject's identity and eye to be treated
2. Subject's eye will be dilated
3. Subject will be positioned at the slit lamp for treatment
4. Application of subthreshold micropulse laser using the Iridex IQ577 laser unit. (intermittent pulsed energy) in a 7 X 7 grid pattern surrounding the fovea.
Micropulse Laser Treatment: Participant's study eye will be dilated prior to being comfortably seated at the slit lamp for treatment. Application of micropulse laser on retinal surface will occur using TxCell Scanning Delivery System in a 7 x 7 grid to surround the fovea.
|
Sham Treatment
n=11 participants at risk
Eyes assigned to the sham arm of the trial will undergo the following procedures:
1. Confirmation of the subject's identity and eye to be treated
2. Subject's eye will be dilated
3. Subject will be positioned at the slit lamp for treatment
4. No Actual laser treatment will occur
Sham Treatment: Participant's study eye will be dilated prior to being comfortably seated at the slit lamp for treatment. No actual laser treatment will occur.
|
|---|---|---|
|
Eye disorders
Worsening Diabetic Macular Edema
|
12.5%
2/16 • Number of events 2 • 6 months
|
0.00%
0/11 • 6 months
|
|
Eye disorders
Vitreous Hemorrhage
|
6.2%
1/16 • Number of events 1 • 6 months
|
9.1%
1/11 • Number of events 1 • 6 months
|
|
Eye disorders
Posterior Vitreous Detachment
|
6.2%
1/16 • Number of events 1 • 6 months
|
0.00%
0/11 • 6 months
|
|
Eye disorders
Decrease in Visual Acuity
|
6.2%
1/16 • Number of events 1 • 6 months
|
9.1%
1/11 • Number of events 1 • 6 months
|
Additional Information
Clinical Research Supervisor
University of California, Davis Eye Center
Phone: 916 734-6303
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place