Green Laser Photocoagulation Study in Proliferative Diabetic Retinopathy

Aurolab

Status and phase: Completed; Phase 3

Conditions: Diabetic Retinopathy

Treatments: Device: Green Laser (Iridex); Device: Green Laser (Aurolas, Aurolab)

Study type: Interventional

Funder types: Other

Identifiers

NCT00355680

2PR1210511

Details and patient eligibility

About

To Demonstrate that indigenous green laser produces similar treatment effect on the retina when compared with already available green laser.

Full description

Proliferative Diabetic Retinopathy is ocular pathology in poor glycaemic controlled Diabetic patient Characterized by micro-vascular pathology with capillary closure in the retina leading to hypoxia of tissue there by formation of immature vessels to provide better oxygenation of retinal tissue.

In this randomized double blinded study a convenient sample size of 24 eyes assigned to compare indigenously developed green laser with already available green laser.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients more than 18 years of age
• Eyes with proliferative diabetic retinopathy requiring laser photocoagulation

Exclusion criteria

• Eyes with media opacities not allowing proper fundus photography or adequate laser photocoagulation
• Patients requiring more than two sessions of laser photocoagulation
• Patients who had undergone previous laser photocoagulation
• Patients who had undergone any previous vitreo-retinal surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

24 participants in 2 patient groups

1

Experimental group

Description:

Aurolab Green Laser

Treatment:

Device: Green Laser (Aurolas, Aurolab)

2

Active Comparator group

Description:

Available Green Laser

Treatment:

Device: Green Laser (Iridex)