Safety and Efficacy of Canaloplasty and Non-penetrating Deep Sclerectomy With Phacoemulsification to Treat Glaucoma and Cataract

Comparison of Safety and Efficacy of Canaloplasty and Non-penetrating Deep Sclerectomy Combined With Phacoemulsification to Treat Glaucoma and Cataract. A Randomised, Prospective Study.

It is a comparative study of Safety and Efficacy of Canaloplasty and Non-penetrating Deep Sclerectomy Combined With Phacoemulsification to Treat Glaucoma and Cataract. It is a Randomised, Prospective Study.

Study Overview

• Status: Unknown
• Conditions: Cataract; Open Angle Glaucoma
• Intervention / Treatment: Procedure: Canaloplasty and phacoemulsification; Procedure: Non-penetrating deep sclerectomy and phacoemulsification

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 04-141
    • Recruiting
    • Military Institute of Medicine
    • Contact: Anna Byszewska, MD; Phone Number: +48 500285890; Email: ania.byszewska@gmail.com
    • Contact: Marek Rekas, MD, PhD Associate Professor of; Phone Number: +48 226816575; Email: rekaspl@gmail.com

Participation Criteria

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 ( open angle glaucoma,pseudoexfoliation syndrome, pigmentary glaucoma)
• eye with characteristic glaucoma changes (biomicroscopic,visual field) with IOP >16mmHg on medication or without, or IOP<16mmHg on 2 or more medications.
• uncontrolled IOP
• patients not tolerating antiglaucoma medications,
• patients with poor compliance
• progression in visual field

Exclusion Criteria:

• previous surgical glaucoma procedure
• previous cataract surgery
• visual function under 0,004
• closed angle glaucoma
• poorly controlled diabetes mellitus
• advanced AMD
• active inflammatory disease
• pregnancy
• mental disease or emotional instability, that could

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Canaloplasty and phacoemulsification	Procedure: Canaloplasty and phacoemulsification; As soon as the two scleral flaps (deep and superficial -similar to deep sclerectomy) are dissected, the phacoemulsification is performed and a artificial lense is implanted. After excision of the deep flap the descemets window and ostia of Schlemm canal are created, the microcatheter is placed in the canal and is advanced 12 clock hours within the canal. Surgeon observes the location of beacon tip through sclera and injects the Healon GV. When the catheterisation of the canal is done, the distal tip is exposed and a 10-0 propylene suture is tied to the distal tip. Then the microcatheter is withdrawn and suture is pulled into the canal. As it appears at the other ostium of canal the microcatheter it separated from the suture. A loop is created, encircling the inner wall of Schlemm canal. Then suture loop is tightened to distend the trabecular meshwork inward, placing the tissues in tension, the locking nods are added. The superficial flap is sutured watertight to prevent bleb formation.
ACTIVE_COMPARATOR: Non-penetrating deep sclerectomy and phacoemulsification	Procedure: Non-penetrating deep sclerectomy and phacoemulsification; A fornix-based conjunctival flap is dissected superiorly, and the sclera is exposed. A 5 x 5 mm scleral flap is dissected anteriorly into clear cornea using a No. 69 Beaver blade. Then the phacoemulsification procedure is performed and a artificial lense is implanted. Afterwards second deep scleral flap is dissected and excised leaving only a thin layer of deep sclera over the choroid. Anteriorly, the dissection is made down to remove Schlemm's canal and juxtacanalicular trabeculum. Excision of the corneal stroma is performed more anteriorly down to Descemet's membrane. This allows aqueous humor to percolate through the thin trabecular-Descemet's membrane. The superficial scleral flap is then closed with two 10-0 monofilament nylon sutures.The conjunctiva is sutured down over the limbus with one interrupted 10-0 monofilament nylon suture at each corner.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IOP	by Goldman tonometry Primary efficacy outcome-proportion of the population that achieves an IOP of >5 and ≤ 21 mmHg, irrespective of glaucoma medication use. Complete success is defined as achieving the target IOP without use of medications. A qualified success is defined as achieving the target IOP with either no change in medications or a reduction in medication as compared to that used preoperatively.	Change from Baseline at 24months
number of antiglaucoma medications		Change from Baseline at 24months
visual acuity	ETDRS chart	Change from Baseline at 24months
intraoperative complications	Rates for surgical complications and adverse events	surgery day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary procedures	Any additional ophtalmic surgical procedures that need to be done within the time frame.	within 24 months
Early and late complications	complications and Adverse effects rate	within 24 months

Collaborators and Investigators

• Sponsor: Military Institute of Medicine, Poland
• Investigators: Study Director: Marek Rekas, MD,PhD,Professor, Military Institute of Medicine, Poland

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (ANTICIPATED): December 1, 2014
• Study Completion (ANTICIPATED): December 1, 2014

Study Registration Dates

• First Submitted: April 17, 2012
• First Submitted That Met QC Criteria: November 10, 2012
• First Posted (ESTIMATE): November 15, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): November 15, 2012
• Last Update Submitted That Met QC Criteria: November 10, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: cataract; glaucoma; ophthalmology; glaucoma surgery; canaloplasty; non-penetrating deep sclerectomy
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Lens Diseases; Glaucoma; Glaucoma, Open-Angle; Cataract
• Other Study ID Numbers: BW1 151/12; BW1151/12 (OTHER: MMIPoland)