Phase 4
N=30
Transfoveal Micropulse Laser for Center Involving Diabetic Macular Edema
Diabetic Retinopathy · Macula Edema
Bottom Line
View on ClinicalTrials.gov: NCT04359771 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Change in Central Retinal Thickness (CRT) — 384.62; 374; 349.15; 357.62 micrometer
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Yellow micro-pulse laser (Device); Diode micro-pulse laser (Device)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Cairo University
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Central Retinal Thickness (CRT) |
384.62; 374; 349.15; 357.62; 321.92; 339.69 | — |
| PRIMARY Change in the Best Corrected Visual Acuity (BCVA) |
0.68; 0.58; 0.60; 0.57; 0.55; 0.52 | — |
Summary
Anti-vascular endothelial growth factor (VEGF) therapy is currently the mainstay of treatment for diabetic macular edema (DME). One of the main obstacles of anti-VEGF therapy is the need of repeated injections, which carries both economic and compliance problems to the patients.there is a growing evidence that recognises the effectiveness of the use of micropulse laser (MPL) in treatment of DME. with MPL, it is possible to deliver a subthreshold laser that is above the threshold of biochemical effect but below the threshold of a visible, destructive lesion thereby preventing collateral damage.The MPL technique is available at near - infrared 810 nm diode laser (diode MPL) and at 577 nm (yellow MPL). The current study was conducted in order to compare the efficacy of both MPL techniques in the treatment of center involving DME.
Eligibility Criteria
Inclusion Criteria
- bilateral diabetic macular edema
- center involving confirmed by Optical coherence tomogram (OCT)
Exclusion Criteria
- any non-diabetic macular edema
- significant media opacities
- previous laser treatment, any intraocular surgery within the past 6 months
- previous intravitreal injections of any drug within the past 6 months
Data sourced from ClinicalTrials.gov (NCT04359771). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.