Glaucoma Treatment using Ultrasound

Not Applicable

Completed

Conditions: Health Condition 1: null- Primary Open Angle Glaucoma

Registration Number: CTRI/2015/05/005810

Lead Sponsor: EyeTechCare

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 90

Inclusion Criteria

1. Patients diagnosed with Primary Open Angle Glaucoma or Pseudo-exfoliative Glaucoma or Pigmentary Glaucoma

2. Patients with/without prior filtering glaucoma surgery

3. Patients where the IOP is not adequately controlled with glaucoma medication, with IOP between greater than or equal to 21 mm Hg and less than or equal to 45 mm Hg

4. No previous intraocular surery or laser treatment during the 90 days before HIFU day

5. Patient able and willing to sign approved informed consent form and agrees to attend all postoperative follow-up visits

Exclusion Criteria

1. Angle closure glaucoma or narrow anatomical anterior chamber as identified by gonioscopy and classified as Shaffer Grade 0 or 1

2. Patients diagnosed with any type of Secondary Glaucoma

3. Glaucoma drainage device implanted and still present in the eye to be treated

4. Previous cyclodestructive procedure in the eye to be treated

5. History of ocular or retrobulbar tumor

6. Ocular infection within 14 days prior to the HIFU procedure

7. Aphakic patient

8. Ocular disease other than glaucoma that may affect assessment of visual acuity and/or IOP

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Successful reduction of intraocular pressure relative to the baseline value will be assessed at 6 months (Success rates and Mean IOP variation in %)Timepoint: 6 months

Secondary Outcome Measures

Name	Time	Method
1. Success/Failure rates at Month1, Month2 and Month3 post-operative visits (% and number of patients) <br/ ><br>2. Mean IOP (mm Hg) at follow-up visits (Day1, Day7, Month1, Month2 and Month3) compared to the baseline IOP <br/ ><br>3. Mean IOP variation compared to the baseline (%) at follow-up visits (Day1, Day7, Month1, Month2 and Month3) <br/ ><br>4. Number of ocular hypotensive medications at each follow-up visitsTimepoint: Day 1, Day 7, Month 1, Month 2 and Month 3