Subthreshold Photocoagulation Using Endpoint Management in the PASCAL® System for Diffuse Diabetic Macular Edema.

Area of Science:

• Ophthalmology
• Retinal Diseases
• Medical Technology

Background:

• Diabetic macular edema (DME) is a leading cause of vision loss in diabetic patients.
• Current treatments for DME may have limitations in efficacy or side effects.
• Subthreshold laser photocoagulation offers a potentially gentler approach to DME treatment.

Purpose of the Study:

• To evaluate the safety and efficacy of subthreshold photocoagulation using endpoint management (EPM) for treating diabetic macular edema (DME).
• To assess the impact of EPM on visual acuity (VA), central macular thickness (CMT), macular volume (MV), and macular sensitivity (MS).

Main Methods:

• A prospective study involving 10 eyes of 10 patients with DME meeting specific CMT and VA criteria.
• Treatment involved grid pattern laser photocoagulation using the PASCAL Streamline Yellow® system at 50% of the threshold.
• Primary endpoints included VA and CMT at 6 months; secondary endpoints included fundus autofluorescence, MV, and MS.

Main Results:

• Significant reduction in CMT was observed at 6 months posttreatment.
• No significant changes in macular sensitivity, best corrected visual acuity (BCVA), or macular volume were noted.
• Complete resolution of macular edema occurred in 40% of eyes after a single treatment, with improved MS in these cases.
• No adverse events like scotoma were reported, and autofluorescence remained unchanged in most eyes.

Conclusions:

• Subthreshold photocoagulation with EPM is a safe and effective treatment for DME.
• The procedure demonstrates potential for reducing macular edema and preserving or improving macular sensitivity.
• EPM offers a promising alternative for DME management with a favorable safety profile.