NCT01975103

Non-damaging Retinal Laser Therapy With PASCAL Laser for Macular Diseases

Phase 2 Study of Non-damaging Retinal Laser Therapy Using PASCAL Laser With Endpoint Management Software for Macular Diseases

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Federal University of Rio Grande do Sul · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This trial seeks to prove the safety and efficacy of photothermal stimulation treatment to diabetic macular edema, chronic central serous retinopathy, macular edema secondary to branch retinal vein occlusion and macular telangiectasia.

Detailed description

Sub-visible, non-damaging photothermal stimulation (532nm) exposures of 100 ms in duration resulted in enhanced expression of heat shock proteins in the retina. To test clinical efficacy of sub-visible retinal therapy using ms-range exposures of visible lasers one needs first to establish proper titration methods necessary to assure on one hand the lack of tissue damage, and on the other hand sufficient hyperthermia to elicit cellular response. We used an algorithm based on computational and experimental data to provide parameters that can cause photothermal stimulation to the retinal pigment epithelium without causing collateral damage to photoreceptors or choroid. This method will be used to treat macular diseases such as diabetic macular edema, branch retinal vein occlusion macular edema, chronic central serous retinopathy and macular telangiectasia.

Conditions

• Diabetic Macular Edema
• Branch Retinal Vein Occlusion
• Chronic Central Serous Retinopathy
• Macular Telangiectasia

Interventions

Type	Name	Description
PROCEDURE	Topcon Endpoint Management

Timeline

• Start date: 2013-03-01
• Primary completion: 2020-04-01
• Completion: 2020-04-01
• First posted: 2013-11-04
• Last updated: 2018-11-14

Locations

1 site across 1 country: Brazil