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

September 17, 2016 updated by: Marek Rekas, Military Institute of Medicine, Poland

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.

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland, 04-141
        • Recruiting
        • Military Institute of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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
Procedure: canaloplasty and phacoemulsification
Other Names:
  • canaloplasty ab externo
  • canaloplasty ab interno
  • minicanaloplasty
ACTIVE_COMPARATOR: 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.
Procedure: canaloplasty and phacoemulsification
Other Names:
  • canaloplasty ab externo
  • canaloplasty ab interno
  • minicanaloplasty
ACTIVE_COMPARATOR: 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
Procedure: canaloplasty and phacoemulsification
Other Names:
  • canaloplasty ab externo
  • canaloplasty ab interno
  • minicanaloplasty

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Military Institute of Medicine, Poland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

September 17, 2016

First Submitted That Met QC Criteria

September 17, 2016

First Posted (ESTIMATE)

September 21, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

September 21, 2016

Last Update Submitted That Met QC Criteria

September 17, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 76/WIM/2015
  • 76/WIM/015 (OTHER: MMI)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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