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

Primary Purpose

Primary Open Angle Glaucoma, Cataract

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
canaloplasty and phacoemulsification
Sponsored by
Military Institute od Medicine National Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open Angle Glaucoma, Cataract focused on measuring open angle glaucoma, canaloplasty, migs, abic

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Military Institute of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

canaloplasty ab externo and phacoemulsification

canaloplasty ab interno and phacoemulsification

minicanaloplasty and phacoemulsification

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 Then a suture is tied to the distal tip and the microcatheter is withdrawn.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

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.

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

Outcomes

Primary Outcome Measures

mean IOP
Number of antiglaucoma drugs
intraoperative complications

Secondary Outcome Measures

Best-Corrected Visual Acuity
Visual Field changes
MD,
Early and Late postsurgical complications
% IOP reduction

Full Information

First Posted
September 17, 2016
Last Updated
September 17, 2016
Sponsor
Military Institute od Medicine National Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02908633
Brief Title
Safety and Efficacy of Three Variants of Canaloplasty With Phacoemulsification to Treat Glaucoma and Cataract
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Military Institute od Medicine National Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma, Cataract
Keywords
open angle glaucoma, canaloplasty, migs, abic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
canaloplasty ab externo and phacoemulsification
Arm Type
Active Comparator
Arm 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
Arm Title
canaloplasty ab interno and phacoemulsification
Arm Type
Active Comparator
Arm 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.
Arm Title
minicanaloplasty and phacoemulsification
Arm Type
Active Comparator
Arm 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
Intervention Type
Procedure
Intervention Name(s)
canaloplasty and phacoemulsification
Other Intervention Name(s)
canaloplasty ab externo, canaloplasty ab interno, minicanaloplasty
Primary Outcome Measure Information:
Title
mean IOP
Time Frame
change form baseline at 24 months
Title
Number of antiglaucoma drugs
Time Frame
change from baseline at 24 months
Title
intraoperative complications
Time Frame
at the day of surgery
Secondary Outcome Measure Information:
Title
Best-Corrected Visual Acuity
Time Frame
change from baseline at 24 months
Title
Visual Field changes
Description
MD,
Time Frame
change from baseline at 24 months
Title
Early and Late postsurgical complications
Time Frame
within 24 months
Title
% IOP reduction
Time Frame
change at 24 months from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marek Rękas, MD, PhD, Professor
Phone
+48604113659
Email
rekaspl@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Aleksandra Kicińska, MD
Phone
+48601339376
Email
aleksandra.kicinska@gmail.com
Facility Information:
Facility Name
Military Institute of Medicine
City
Warsaw
ZIP/Postal Code
04-141
Country
Poland
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
31377849
Citation
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.
Results Reference
derived

Learn more about this trial

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

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