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

Study Overview
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Brief Summary
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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

Official Title
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HFDS ab Interno - to Compare Intraocular Pressure (IOP) Lowering Effect of Combined High Frequency Deep Sclerotomy ab Interno (HFDS ab Interno) With Phacoemulsification and Phacoemulsification Alone, in Primary Open Angle Glaucoma Patients

Conditions
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Cataract, Glaucoma, POAG

Intervention / Treatment
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* Procedure: Combined sclerotomy ab interno and phaco
* Procedure: Phacoemulsification with IOL implantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined sclerotomy ab interno and phaco<br>Combined sclerotomy ab interno and phacoemulsification with IOL implantation | Procedure: Combined sclerotomy ab interno and phaco<br> <br> * Other names: Cataract surgery combined with HFDS;|
| Active Comparator: Phacoemulsification with IOL implantation<br>Phacoemulsification with IOL implantation | Procedure: Phacoemulsification with IOL implantation<br> <br> * Other names: Cataract Surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure |  | Baseline screening till 3 year post-op | 
| visual acuity |  | Baseline screening till 3 year post-op | 
| decrease in anti glaucoma medications |  | Baseline screening till 3 year post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HFDS, ab interno, MIGS, surgery