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

Primary Open Angle Glaucoma, Cataract Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02908633
• Other study ID #: 76/WIM/2015
• Secondary ID: 76/WIM/015
• Status: Recruiting
• Phase: N/A
• First received: September 17, 2016
• Last updated: September 17, 2016
• Start date: February 2016
• Est. completion date: December 2019

Study information

• Verified date: September 2016
• Source: Military Institute of Medicine, Poland
• Contact: Marek Rekas, MD, PhD , Professor
• Phone: +48604113659
• Email: rekaspl[@]gmail.com
• Is FDA regulated: No
• Health authority: Poland: MMI Ethics committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Glaucoma
• Glaucoma, Open-Angle
• Primary Open Angle Glaucoma, Cataract

Intervention

Procedure:
• canaloplasty and phacoemulsification

Locations

Country	Name	City	State
Poland	Military Institute of Medicine	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Military Institute of Medicine, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean IOP		change form baseline at 24 months	No
Primary	Number of antiglaucoma drugs		change from baseline at 24 months	No
Primary	intraoperative complications		at the day of surgery	No
Secondary	Best-Corrected Visual Acuity		change from baseline at 24 months	No
Secondary	Visual Field changes	MD,	change from baseline at 24 months	No
Secondary	Early and Late postsurgical complications		within 24 months	No
Secondary	% IOP reduction		change at 24 months from baseline	No