CTRI/2019/12/022443
Active, not recruiting
Phase 1
A PROSPECTIVE TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF THE g-STEAM (SCLERAL TRANSLOCATION ELASTO-MODULATION) PROCEDURE FOR THE TREATMENT OF PRIMARY GLAUCOMA IN INDIAN ADULTS
ALeyeGN Technologies LLC0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Health Condition 1: H402- Primary angle-closure glaucoma
- Sponsor
- ALeyeGN Technologies LLC
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •First Phase:
- •1\. Male and female subjects are eligible for the study if they are 18 years old or older and have given written informed consent
- •2\. Low visual potential BCDVA \< 2/60
- •3\. Having primary or secondary glaucoma with no or low visual potential and high IOP / or on treatment for the same
- •Second Phase:
- •1\. Male and female subjects are eligible for the study if they are 18 years old or older and 80 years old or less and have given informed consent
- •2\. Subject with OHT or POAG with IOP 18\- 35 mmHg
- •3\. May include PACG after YAG PI (Iridotomy patency and location documented) and requiring medical management.
- •4\. Requiring one or more anti\-glaucoma medication for IOP control
- •5\. Noncompliance, poor control or intolerability/allergy to topical hypotensive treatments
Exclusion Criteria
- •First Phase:
- •1\. Patients younger than 18 years or older than 80 years
- •2\. Sighted patients BCDVA \>2/60
- •3\. Known allergy to involved topical medications
- •4\. Severe systemic disease (i.e. uncontrolled diabetes mellitus, unstable collagen vascular diseases, etc.)
- •5\. Disabling physical conditions
- •6\. Pregnant or nursing women
- •7\. Unable to return for scheduled follow\-up visits
- •8\. Unable to understand protocol
- •Second Phase
Outcomes
Primary Outcomes
Not specified
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