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.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- mean IOP
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
canaloplasty ab externo and phacoemulsification
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 Then a suture is tied to the distal tip and the microcatheter is withdrawn.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
Intervention: canaloplasty and phacoemulsification (Procedure)
canaloplasty ab interno and phacoemulsification
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.
Intervention: canaloplasty and phacoemulsification (Procedure)
minicanaloplasty and phacoemulsification
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
Intervention: canaloplasty and phacoemulsification (Procedure)
Outcomes
Primary Outcomes
mean IOP
Time Frame: change form baseline at 24 months
Number of antiglaucoma drugs
Time Frame: change from baseline at 24 months
intraoperative complications
Time Frame: at the day of surgery
Secondary Outcomes
- Early and Late postsurgical complications(within 24 months)
- Best-Corrected Visual Acuity(change from baseline at 24 months)
- Visual Field changes(change from baseline at 24 months)
- % IOP reduction(change at 24 months from baseline)
Investigators
Marek Rekas
MD, PhD Professor of Ophthalmology
Military Institute od Medicine National Research Institute