Safety and Efficacy of Canaloplasty and Non-penetrating Deep Sclerectomy 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 Canaloplasty and Non-penetrating Deep Sclerectomy 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 Canaloplasty and Non-penetrating Deep Sclerectomy Combined With Phacoemulsification to Treat Glaucoma and Cataract. A Randomised, Prospective Study.

Conditions
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Open Angle Glaucoma, Cataract

Intervention / Treatment
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* Procedure: Canaloplasty and phacoemulsification
* Procedure: Non-penetrating deep sclerectomy and phacoemulsification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: co-existing glaucoma and cataract glaucoma types ( open angle glaucoma,pseudoexfoliation syndrome, pigmentary glaucoma) eye with characteristic glaucoma changes (biomicroscopic,visual field) with IOP >16mmHg on medication or without, or IOP<16mmHg on 2 or more medications. uncontrolled IOP patients not tolerating antiglaucoma medications, patients with poor compliance progression in visual field Exclusion Criteria: previous surgical glaucoma procedure previous cataract surgery visual function under 0,004 closed angle glaucoma poorly controlled diabetes mellitus advanced AMD active inflammatory disease pregnancy mental disease or emotional instability, that could

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 and phacoemulsification<br> | Procedure: Canaloplasty and phacoemulsification<br>* As soon as the two scleral flaps (deep and superficial -similar to deep sclerectomy) are dissected, the phacoemulsification is performed and a artificial lense is implanted. After excision of the deep flap the descemets window and ostia of Schlemm canal are created, the microcatheter is placed in the canal and is advanced 12 clock hours within the canal. Surgeon observes the location of beacon tip through sclera and injects the Healon GV. When the catheterisation of the canal is done, the distal tip is exposed and a 10-0 propylene suture is tied to the distal tip. Then the microcatheter is withdrawn and suture is pulled into the canal. As it appears at the other ostium of canal the microcatheter it separated from the suture. A loop is created, encircling the inner wall of Schlemm canal. Then suture loop is tightened to distend the trabecular meshwork inward, placing the tissues in tension, the locking nods are added. The superficial flap is sutured watertight to prevent bleb formation.<br>|
| Active Comparator: Non-penetrating deep sclerectomy and phacoemulsification<br> | Procedure: Non-penetrating deep sclerectomy and phacoemulsification<br>* A fornix-based conjunctival ﬂap is dissected superiorly, and the sclera is exposed. A 5 x 5 mm scleral ﬂap is dissected anteriorly into clear cornea using a No. 69 Beaver blade. Then the phacoemulsification procedure is performed and a artificial lense is implanted. Afterwards second deep scleral ﬂap is dissected and excised leaving only a thin layer of deep sclera over the choroid. Anteriorly, the dissection is made down to remove Schlemm's canal and juxtacanalicular trabeculum. Excision of the corneal stroma is performed more anteriorly down to Descemet's membrane. This allows aqueous humor to percolate through the thin trabecular-Descemet's membrane. The superficial scleral ﬂap is then closed with two 10-0 monofilament nylon sutures.The conjunctiva is sutured down over the limbus with one interrupted 10-0 monofilament nylon suture at each corner.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP | by Goldman tonometry Primary efficacy outcome-proportion of the population that achieves an IOP of >5 and ≤ 21 mmHg, irrespective of glaucoma medication use. Complete success is defined as achieving the target IOP without use of medications. A qualified success is defined as achieving the target IOP with either no change in medications or a reduction in medication as compared to that used preoperatively. | Change from Baseline at 24months | 
| number of antiglaucoma medications |  | Change from Baseline at 24months | 
| visual acuity | ETDRS chart | Change from Baseline at 24months | 
| intraoperative complications | Rates for surgical complications and adverse events | surgery day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary procedures | Any additional ophtalmic surgical procedures that need to be done within the time frame. | within 24 months | 
| Early and late complications | complications and Adverse effects rate | within 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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canaloplasty, non-penetrating deep sclerectomy, glaucoma, cataract, ophthalmology, glaucoma surgery