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

Not Applicable

• Conditions: Cataract; Glaucoma; POAG
• Interventions: Procedure: Phacoemulsification with IOL implantation; Procedure: Combined sclerotomy ab interno and phaco

• 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

Arm && Interventions

Group	Intervention	Description
Phacoemulsification with IOL implantation	Phacoemulsification with IOL implantation	Phacoemulsification with IOL implantation
Combined sclerotomy ab interno and phaco	Combined sclerotomy ab interno and phaco	Combined sclerotomy ab interno and phacoemulsification with IOL implantation

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