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Clinical Trials/CTRI/2019/12/022443
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
ALeyeGN Technologies LLC

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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