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

M

Military Institute od Medicine National Research Institute

Status

Unknown

Conditions

Primary Open Angle Glaucoma, Cataract

Treatments

Procedure: canaloplasty and phacoemulsification

Study type

Interventional

Funder types

Other

Identifiers

NCT02908633
76/WIM/2015
76/WIM/015 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

90 estimated patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

90 participants in 3 patient groups

canaloplasty ab externo and phacoemulsification
Active Comparator group
Description:
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 Then a suture is tied to the distal tip and the microcatheter is withdrawn.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
Treatment:
Procedure: canaloplasty and phacoemulsification
canaloplasty ab interno and phacoemulsification
Active Comparator group
Description:
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.
Treatment:
Procedure: canaloplasty and phacoemulsification
minicanaloplasty and phacoemulsification
Active Comparator group
Description:
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
Treatment:
Procedure: canaloplasty and phacoemulsification

Trial contacts and locations

1

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Central trial contact

Marek Rękas, MD, PhD, Professor; Aleksandra Kicińska, MD

Data sourced from clinicaltrials.gov

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