To Study the Safety and Effectiveness of New LASER Treatment in Glaucoma patients
- Conditions
- Health Condition 1: H402- Primary angle-closure glaucoma
- Registration Number
- CTRI/2019/12/022443
- Lead Sponsor
- ALeyeGN Technologies LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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
6. Diagnosis of glaucoma based on findings of
i. Glaucomatous optic neuropathy (GON)
ii. Field defects typical of glaucoma in a reliable visual field and/or OCT for retinal nerve fiber layer (RNFL) thinning IOP and gonioscopy
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
1. Patients younger than 18 years or older than 80 years
2. Advanced glaucoma with threat of loss of central visual fixation on perimetry
3. History of previous laser trabeculoplasty (LT) in the study eye
4. Severe eye trauma or uveitis
5. Inflammatory Peripheral anterior synechiae (PAS)
6. Use of systemic / topical steroids within the previous 3 months
7. Ocular surgery of any type within the previous 6 months
8. Trabeculectomy or glaucoma shunt surgery anytime
9. Media opacities interfering with gonioscopic or optic nerve evaluations
10. Best corrected distance visual acuity (BCDVA) of 20/200 or worse in the fellow eye
11. Central retinal vein occlusion (CRVO), branch vein occlusion (BRVO), or central retinal artery occlusion (CRAO), proliferative Diabetic retinopathy, uveitis, retinal degeneration in the fellow eye and/or study eye.
12. Known allergy to involved topical medications
13. Severe systemic disease (i.e. diabetes mellitus, collagen vascular diseases, etc.)
14. Disabling physical conditions
15. Pregnant or nursing women
16. Unable to return for scheduled follow-up visits
17. Unable to understand protocol
18. Secondary glaucoma
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. The frequency and severity of all treatment-related adverse events, during and after the g-STEAM Procedure for first month and throughout the 6-month follow-up period. Adverse events will be assessed on a continuous basis from the day of the procedure through the study completion at 6 months. <br/ ><br>2. Need for adjunct surgery <br/ ><br>3. Presence Inflammatory markers in tear secretion <br/ ><br>4. Any Complications <br/ ><br>5. Any significant changes on Ultrasound bio-microscopy (UBM)Timepoint: First Phase <br/ ><br>Day 0, 60 minutes, Day 1, 7, 30, 90 <br/ ><br>Second Phase: <br/ ><br>Day 0, 60 minutes, Day 1, 7, 30, 90, 180, 360 (optional) <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1. IOP measured by GAT or by Tonopen in case of irregular cornea. <br/ ><br>2. ECD/ECC if permitted by the corneal clarity <br/ ><br>3. Elevation Inflammatory markers in tears such as IL6, TNFa, IL1b, MMP9, IL8, bFGF, TGFb, TIMP1 <br/ ><br>4.PRO and related collateral effects <br/ ><br>For Sighted Eyes: <br/ ><br>Additionally, the following endpoints will be measured: <br/ ><br>1. Visual Field Assessment <br/ ><br>2. Best Corrected Distance Visual Acuity (BCVA)Timepoint: First Phase <br/ ><br>Day 0, 60 minutes, Day 1, 7, 30, 90 <br/ ><br>Second Phase: <br/ ><br>Day 0, 60 minutes, Day 1, 7, 30, 90, 180, 360 (optional) <br/ ><br>