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

Phase 4

Recruiting

• 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

Study Timeline

• Last Update Posted: 2023-05-01

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