Safety and Efficacy of Three Variants of Canaloplasty With Phacoemulsification to Treat Glaucoma and Cataract

Study Overview
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Brief Summary
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It is a comparative study of Safety and Efficacy of Three Variants of Canaloplasty: ab-externo, ab-interno and minicanaloplasty. Combined With Phacoemulsification to Treat Glaucoma and Cataract. It is a Randomised, Prospective Study.

Official Title
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Comparison of Safety and Efficacy of Three Variants of Canaloplasty: Ab-externo, Ab-interno and Minicanaloplasty Combined With Phacoemulsification to Treat Glaucoma and Cataract. A Randomised, Prospective Study.

Conditions
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Primary Open Angle Glaucoma, Cataract

Intervention / Treatment
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* Procedure: canaloplasty and phacoemulsification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: co-existing glaucoma and cataract glaucoma types: primary open angle glaucoma, eye with characteristic glaucoma changes (biomicroscopic,visual field) IOP over 21 mmHg after washout patients not tolerating antiglaucoma medications, patients with poor compliance progression in visual field Exclusion Criteria: previous surgical glaucoma procedure previous cataract surgery BCVA under 0,004 closed angle glaucoma secondary glaucoma (pseudoexfoliative, pigmentary) poorly controlled diabetes mellitus advanced AMD active inflammatory disease pregnancy mental disease or emotional instability general steroid therapy

Ages Eligible for Study
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Minimum Age: 21 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: canaloplasty ab externo and phacoemulsification<br>As soon as the two scleral flaps: deep and superficial -similar to deep sclerectomy are dissected, the phacoemulsification with PCIOL insertion is performed. After excision of the deep flap the descemets window and ostia of Schlemm canal are created, the microcatheter is placed in the canal and guided for 360 degrees within the canal. Surgeon observes the location of beacon tip through sclera and injects the Healon GV. Then a suture is tied to the distal tip and the microcatheter is withdrawn. As it appears at the other ostium of canal the microcatheter it separated from the suture.Then suture loop is tightened to tension the trabecular meshwork. The superficial flap is sutured watertight to prevent bleb formation | Procedure: canaloplasty and phacoemulsification<br> <br> * Other names: minicanaloplasty;|
| Active Comparator: canaloplasty ab interno and phacoemulsification<br>This variant of canaloplasty spares conjunctival surface. First phacoemulsification and PCIOL placement is performed. The Schlemm's canal is reached through goniotomy through anterior chamber. Similarly microcatheter is inserted and viscodilatator applicated. The key difference, is that no tensioning suture is left after the catheter is withdrawn. phacoemulsification is performed. | Procedure: canaloplasty and phacoemulsification<br> <br> * Other names: minicanaloplasty;|
| Active Comparator: minicanaloplasty and phacoemulsification<br>The dissected conjunctival flap is of minimal size. The scleral flaps are sized: superficial flap 3x1mm, and deep flap: 1x1 mm- with no removal of the deep flap. Afterwards phacoemulsification part is performed. The microcatheterization and viscodilatation are conducted as in the traditional procedure.The conjunctiva is closed with one suture or coagulation | Procedure: canaloplasty and phacoemulsification<br> <br> * Other names: minicanaloplasty;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean IOP |  | change form baseline at 24 months | 
| Number of antiglaucoma drugs |  | change from baseline at 24 months | 
| intraoperative complications |  | at the day of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best-Corrected Visual Acuity |  | change from baseline at 24 months | 
| Visual Field changes | MD, | change from baseline at 24 months | 
| Early and Late postsurgical complications |  | within 24 months | 
| % IOP reduction |  | change at 24 months from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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open angle glaucoma, canaloplasty, migs, abic