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

NCT ID: NCT02908633

Last Updated: 2016-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2019-12-31

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.

Detailed Description

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Conditions

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Primary Open Angle Glaucoma, Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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 Then a suture is tied to the distal tip and the microcatheter is withdrawn.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

Group Type ACTIVE_COMPARATOR

canaloplasty and phacoemulsification

Intervention Type 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.

Group Type ACTIVE_COMPARATOR

canaloplasty and phacoemulsification

Intervention Type 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

Group Type ACTIVE_COMPARATOR

canaloplasty and phacoemulsification

Intervention Type PROCEDURE

Interventions

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canaloplasty and phacoemulsification

Intervention Type PROCEDURE

Other Intervention Names

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canaloplasty ab externo canaloplasty ab interno minicanaloplasty

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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Military Institute od Medicine National Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Marek Rekas

MD, PhD Professor of Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Military Institute of Medicine

Warsaw, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Marek Rękas, MD, PhD, Professor

Role: CONTACT

+48604113659

Aleksandra Kicińska, MD

Role: CONTACT

+48601339376

References

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Danielewska ME, Kicinska AK, Placek MM, Lewczuk K, Rekas M. Changes in spectral parameters of corneal pulse following canaloplasty. Graefes Arch Clin Exp Ophthalmol. 2019 Nov;257(11):2449-2459. doi: 10.1007/s00417-019-04433-9. Epub 2019 Aug 3.

Reference Type DERIVED
PMID: 31377849 (View on PubMed)

Other Identifiers

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76/WIM/015

Identifier Type: OTHER

Identifier Source: secondary_id

76/WIM/2015

Identifier Type: -

Identifier Source: org_study_id

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