Clinical study to evaluate the efficacy of a surgical procedure (Selective Laser Trabeculoplasty) in glaucoma patients in Indian population.

Phase 4

Conditions: Health Condition 1: O- Medical and SurgicalHealth Condition 2: H401- Open-angle glaucoma

Registration Number: CTRI/2022/07/044032

Lead Sponsor: Carl Zeiss India Bangalore Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Patients with mild to moderate primary open angle glaucoma who are eligible to undergo SLT treatment in one or both eyes

2. IOP with or without medication >= 21 mmHg in the study eye

3. Patients willing to give informed consent

4. Patients are willing and able to return for follow-up examinations

5.In the opinion of the investigator, the patient will be compliant and have a high probability of completing the data collection and all required procedures

Exclusion Criteria

1. Very advanced glaucoma in either eye

2. Congenital glaucoma

3. Angle closure glaucoma, both primary and secondary

4. Corneal disease or pathology in a way that distortion of laser light in the treated eye can be expected or that precludes stabilization of the cornea by the contact glass, visibility of the trabecular meshwork or transmission of laser wavelength

5. Any known contraindication to SLT which include

a. Angle closure glaucoma if trabecular meshwork is not visible

b. Neovascular glaucoma

c. Acute inflammatory glaucoma

d. Blood vessels in the Schlemm canal

6. Any kind of planned ocular surgeries during the next 3 months, for example, cataract surgery, in either eye

7. History of intraocular surgery, ALT, or angle-based surgery

8. Enrollment in another drug or device study within the prior 3 months

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The endpoint is the mean change in intraocular pressure (IOP) of the patient cohort compared to baseline at month 3 (primary analysis) and month 6 (secondary analysis) <br/ ><br>1. Absolute value (mmHg, primary endpoint) <br/ ><br>2. Relative value (%, secondary endpoint) <br/ ><br>Timepoint: Preoperative Visit - Day -180 to Day 0 <br/ ><br>Operative visit - Day 0 <br/ ><br>Post op visit Day 1 <br/ ><br>Post op visit Month 1 <br/ ><br>Post op visit Month 3 <br/ ><br>Post op visit Month 6

Secondary Outcome Measures

Name	Time	Method
The following exploratory endpoints will be determined additionally <br/ ><br>1. Percentage of patients with more than equal to 20 percent IOP reduction <br/ ><br>2. Subgroup analysis of treatment naive patients and adjunctive therapy <br/ ><br>3. Change in glaucoma medication with respect to number and dosage <br/ ><br>4. Need to receive further glaucoma treatment within 6 months post SLTTimepoint: 1 month, 3 months and 6 months