To Study the safety and effectiveness of Laser Treatment in Glaucoma patients

Not Applicable

Completed

• Conditions: Health Condition 1: null- Unilateral Glaucoma in Sighted and Unsighted Patients

• Registration Number: CTRI/2017/03/008071
• Lead Sponsor: Aleyegn Technologies LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-05-30
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

•Male and female subjects are eligible for the study if they are 18 years old or older and have given informed consent

•Have moderate to severe glaucoma (24 mm Hg to 45 mm Hg IOP) with or without visual field damage

•Have primary open angle glaucoma, angle closure glaucoma, ocular hypertension, secondary glaucoma, previous intraocular surgery

•Are able to follow up for one year

•Able to provide written informed consent

Exclusion Criteria

•Patients younger than 18 years or older than 80 years

•Patients not willing to participate in the study

•Patients having Vernal Keratoconjunctivitis

•Corneal Scar / corneal dystrophy / corneal degeneration

•Inflammatory conditions

•Patients with corneal hydrops

•Patients with Diabetes, Thyroid Dysfunction, Collagen-Vascular Disorders, Auto-Immune Disorders; Hypertensives can be included provided there would be no change in the systemic treatment during the study period

•Patients not able to come for follow up

•Ultrasonic pachymetry <400 µm

•Eyes with any ocular surface infection

•Endothelial cell count <2000 cells/mm2

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accommodative amplitude change from pre-Op on Binocular Auto-refractor (Grand Seiko 5500) <br/ ><br>Timepoint: Pre-Op (-30 days). Day of surgery (Day 0), Post-Op: Day 1, Week 1, Month 1, Month 3, Month 6, and Month 12.