High Frequency Deep Sclerotomy (HFDS) ab Interno a Combination Surgical Intervention Using Cataract Surgery to Lower IOP

Not Applicable

• Conditions: Cataract; Glaucoma; POAG

• Registration Number: NCT02312362
• Lead Sponsor: Oertli Instrumente AG

Brief Summary

Objective:

To compare intraocular pressure lowering effect of combined sclerotomy ab interno with phacoemulsification and phacoemulsification alone, in primary or secondary open angle glaucoma patients.

Study design:

Prospective, randomized, case- control interventional surgical trial

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Status Verified: 2014-12
• Study First Submitted: 2014-12-05
• Study First Submitted QC: 2014-12-05
• Last Update Submitted: 2014-12-05
• Study First Posted: 2014-12-09
• Last Update Posted: 2014-12-09
• Primary Completion: 2015-06
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

Patients suffering from primary open-angle glaucoma (POAG) inadequately controlled with maximum tolerated medical therapy and who will be treated with cataract surgery.

Exclusion Criteria

• One eyed patients
• Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits
• The presence of extreme narrow angle with complete or partial closure in either eye, except for occludable angles treated with a patent iridectomy
• Any abnormality preventing reliable applanation tonometry, any opacity or patient uncooperativeness that would restrict adequate examination of the ocular fundus or anterior chamber of either eye
• The risk of visual field or visual acuity worsening as a consequence of participation in the trial, in the investigator's opinion
• Any clinically significant, serious, or severe medical or psychiatric condition; any condition that, in the investigator's opinion, would interfere with optimal participation in the study or present a special risk to the patient
• Participation in any other investigational study within 30 days prior to baseline visit

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Intraocular pressure	Baseline screening till 3 year post-op
decrease in anti glaucoma medications	Baseline screening till 3 year post-op
visual acuity	Baseline screening till 3 year post-op