Trial Outcomes & Findings for Transfoveal Micropulse Laser for Center Involving Diabetic Macular Edema (NCT NCT04359771)

Results Overview

detecting changes in the thickness of the center of the macula

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

15 participants

Primary outcome timeframe

baseline, at 1 month and 3 months after the intervention

Results posted on

2020-06-01

Participant Flow

one eye (Right) from each patient was assigned to one arm (yellow MPL) and the other eye (Left) of the same patient to the 2nd arm (diode MPL). Therefore, the total number of enrolled participants was 15 contributing to total of 30 eyes (units) i.e there were 15 participants contributing to 15 eyes in each arm of the study.

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	Yellow MPL Yellow micro-pulse laser: applying 577-nm yellow laser in a micro-pulse mode over the macular area including the fovea. One eye (right) of each participant was assigned to this group.	Diode MPL Diode micro-pulse laser: applying 810-nm infra-red diode laser in a micro-pulse mode over the macular area including the fovea. One eye (left) of each participant was assigned to this group.
Overall Study STARTED	15 15	15 15
Overall Study COMPLETED	13 13	13 13
Overall Study NOT COMPLETED	2 2	2 2

Reasons for withdrawal

Reasons for withdrawal
Measure	Yellow MPL Yellow micro-pulse laser: applying 577-nm yellow laser in a micro-pulse mode over the macular area including the fovea. One eye (right) of each participant was assigned to this group.	Diode MPL Diode micro-pulse laser: applying 810-nm infra-red diode laser in a micro-pulse mode over the macular area including the fovea. One eye (left) of each participant was assigned to this group.
Overall Study Lack of Efficacy	2	2

Baseline Characteristics

two participants were excluded due to lack of efficacy.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Yellow MPL n=13 Participants Yellow micro-pulse laser: applying 577-nm yellow laser in a micro-pulse mode over the macular area including the fovea	Diode MPL n=13 Participants Diode micro-pulse laser: applying 810-nm infra-red diode laser in a micro-pulse mode over the macular area including the fovea	Total n=26 Participants Total of all reporting groups
Age, Continuous	58.23 years STANDARD_DEVIATION 8.03 • n=13 Participants • two participants were excluded due to lack of efficacy.	58.23 years STANDARD_DEVIATION 8.03 • n=13 Participants • two participants were excluded due to lack of efficacy.	58.23 years STANDARD_DEVIATION 8.03 • n=26 Participants • two participants were excluded due to lack of efficacy.
Sex: Female, Male Female	5 Participants n=13 Participants • two participants were excluded due to lack of efficacy.	5 Participants n=13 Participants • two participants were excluded due to lack of efficacy.	10 Participants n=26 Participants • two participants were excluded due to lack of efficacy.
Sex: Female, Male Male	8 Participants n=13 Participants • two participants were excluded due to lack of efficacy.	8 Participants n=13 Participants • two participants were excluded due to lack of efficacy.	16 Participants n=26 Participants • two participants were excluded due to lack of efficacy.
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Egypt	13 participants n=13 Participants • two participants were excluded due to lack of efficacy	13 participants n=13 Participants • two participants were excluded due to lack of efficacy	13 participants n=26 Participants • two participants were excluded due to lack of efficacy

PRIMARY outcome

Timeframe: baseline, at 1 month and 3 months after the intervention

detecting changes in the thickness of the center of the macula

Outcome measures

Outcome measures
Measure	Yellow MPL n=13 eyes Yellow micro-pulse laser: applying 577-nm yellow laser in a micro-pulse mode over the macular area including the fovea	Diode MPL n=13 eyes Diode micro-pulse laser: applying 810-nm infra-red diode laser in a micro-pulse mode over the macular area including the fovea
Change in Central Retinal Thickness (CRT) Baseline	384.62 micrometer Standard Deviation 147.06	374 micrometer Standard Deviation 130.42
Change in Central Retinal Thickness (CRT) 1 month	349.15 micrometer Standard Deviation 141.78	357.62 micrometer Standard Deviation 116.23
Change in Central Retinal Thickness (CRT) 3 months	321.92 micrometer Standard Deviation 126.65	339.69 micrometer Standard Deviation 111.94

PRIMARY outcome

Timeframe: baseline, at 1 month and 3 months after the intervention

detecting changes in the the best corrected visual acuity in logMAR. A LogMAR chart comprises rows of letters and is used by ophthalmologists, optometrists and vision scientists to estimate visual acuity. This chart was developed at the National Vision Research Institute of Australia in 1976, and is designed to enable a more accurate estimate of acuity than do other charts (e.g., the Snellen chart). For this reason, the LogMAR chart is recommended, particularly in a research setting. A Snellen score of 6/6 (20/20), indicating that an observer can resolve details as small as 1 minute of visual angle, corresponds to a LogMAR of 0 (since the base-10 logarithm of 1 is 0); a Snellen score of 6/12 (20/40), indicating an observer can resolve details as small as 2 minutes of visual angle, corresponds to a LogMAR of 0.3 (since the base-10 logarithm of 2 is near-approximately 0.3), and so on.Therefore, a higher logMAR scores mean a worse outcome.

Outcome measures

Outcome measures
Measure	Yellow MPL n=13 eyes Yellow micro-pulse laser: applying 577-nm yellow laser in a micro-pulse mode over the macular area including the fovea	Diode MPL n=13 eyes Diode micro-pulse laser: applying 810-nm infra-red diode laser in a micro-pulse mode over the macular area including the fovea
Change in the Best Corrected Visual Acuity (BCVA) Baseline	0.68 logMar Standard Deviation 0.30	0.58 logMar Standard Deviation 0.28
Change in the Best Corrected Visual Acuity (BCVA) 1 month	0.60 logMar Standard Deviation 0.33	0.57 logMar Standard Deviation 0.29
Change in the Best Corrected Visual Acuity (BCVA) 3 months	0.55 logMar Standard Deviation 0.34	0.52 logMar Standard Deviation 0.31

Adverse Events

Yellow MPL

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Diode MPL

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ahmed Abdelbaki

faculty of medicine, Cairo University

Phone: 00201066642728

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place