Combined Viscocanalostomy, Phacoemulsification, OIogen Implant in Open Angle Glaucoma

Study Overview
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Brief Summary
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This prospective, interventional, randomized clinical study was done at Alpha Vision Center, Zagazig, Egypt. Patients with coexisting cataract and glaucoma were randomized to receive either phaco-viscocanalostomy (Phacovisco group) or phaco-viscocanalostomy with Ologen® implant (OloPhacovisco group) . Follow-up period was 2 years. Nd:YAG laser goniopuncture was done in cases where the intraocular pressure (IOP) was elevated above 21 mmHg after discontinuation of corticosteroid eye drops at any follow-up visit. Our hypothesis is that using Ologen® implant as a spacer in the subscleral reservoir in phaco-viscocanalostomy reduces fibrosis and increase the success rate of this operation

Detailed Description
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Background: To study the efficacy of the biodegradable collagen implant Ologen® as an adjuvant in phaco-viscocanalostomy in patients with coexisting cataract and primary open angle glaucoma. Methods: This prospective, interventional, randomized clinical study was done at Alpha Vision Center, Zagazig, Egypt. Patients with coexisting cataract and glaucoma were randomized to receive either phaco-viscocanalostomy (Phacovisco group) or phaco-viscocanalostomy with Ologen® implant (OloPhacovisco group). Follow-up period was 2 years. Nd:YAG laser goniopuncture was done in cases where the intraocular pressure (IOP) was elevated above 21 mmHg after discontinuation of corticosteroid eye drops at any follow-up visit.

Official Title
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Combined Phacoemulsification and Viscocanalostomy With Ologen Implant Versus Combined Phacoemulsification and Viscocanalostomy

Conditions
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Primary Open-angle Glaucoma

Intervention / Treatment
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* Procedure: combined phacoemulsification and viscocanalostomy
* Procedure: combined phacoemulsification and viscocanalostomy and ologen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: the presence of significant cataract interfering with vision (visual acuity ≤ 0.5) in the presence POAG. if cataract was associated with uncontrolled glaucoma, (IOP > 21 mmHg despite maximally tolerated medical therapy) if the IOP was ≤ 21 mmHg with use of at least two antiglaucoma drugs with medication intolerance poor patient compliance patients could not attend medical supervision patients had visual field deterioration. Exclusion Criteria: closed-angle glaucoma other types of open angle glaucoma (OAG), e.g. pigmentary glaucoma, inflammatory glaucoma or neovascular glaucoma, previous ocular trauma or surgery lens subluxation any eye diseases affecting the vision, e.g. anterior uveitis if there was a large perforation of the Descemet's membrane with iris prolapse during surgery (cases with microperforation, which is defined as small perforation with no associated iris prolapse, occurring during surgery were not excluded) intraoperative complications that might affect the IOP, e.g. vitreous loss.

Ages Eligible for Study
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Minimum Age: 40 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 |
| --- | --- |
| Active Comparator: Phacovisco group<br>group had combined phacoemulsification and viscocanalostomy | Procedure: combined phacoemulsification and viscocanalostomy<br>* phacoemulsification with viscocanalostomy<br>* Other names: phaco-visco-canalostomy;|
| Active Comparator: OloPhacovisco group<br>group had combined phacoemulsification and viscocanalostomy and Ologen | Procedure: combined phacoemulsification and viscocanalostomy and ologen<br>* phacoemulsification with viscocanalostomy with ologen<br>* Other names: phaco-visco-canalostomy with ologen implant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the intraocular pressure | measured by mmHg using Goldman applanatin tonometry | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgical complications | number of surgical complications encountered | 2 years | 
| the use and results of Nd:YAG laser goniopuncture | number of cases needed goniopuncture | 2 years | 
| visual acuity results | visual acuity measured by decimal system | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Viscocanalostomy, Ologen, glaucoma, phacoemulsification