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

NCT01726543 | Unknown

• 2 other identifiers: BW1 151/12BW1151/12
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Open Angle Glaucoma; Cataract

Keywords

canaloplasty; non-penetrating deep sclerectomy; glaucoma; cataract; ophthalmology; glaucoma surgery

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Secondary procedures

  within 24 months

• Early and late complications

  within 24 months

Study Arms (2)

Canaloplasty and phacoemulsification

ACTIVE COMPARATOR

Procedure: Canaloplasty and phacoemulsification

Non-penetrating deep sclerectomy and phacoemulsification

ACTIVE COMPARATOR

Procedure: Non-penetrating deep sclerectomy and phacoemulsification

Interventions

Canaloplasty and phacoemulsification PROCEDURE

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 Then the microcatheter is withdrawn and suture is pulled into the canal.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.

Canaloplasty and phacoemulsification

Non-penetrating deep sclerectomy and phacoemulsification PROCEDURE

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.

Non-penetrating deep sclerectomy and phacoemulsification

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Military Institute od Medicine National Research Institute: lead

Study Sites (1)

Military Institute of Medicine

Warsaw, 04-141, Poland

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle; Cataract; Glaucoma

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Lens Diseases

Intervention Hierarchy (Ancestors)

Cataract Extraction; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Ultrasonic Surgical Procedures

Study Officials

• Marek Rekas, MD,PhD,Professor

  Military Institute od Medicine National Research Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD Associate Professor of Ophthalmology

Study Record Dates

• First Submitted: April 17, 2012
• First Posted: November 15, 2012
• Study Start: February 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 15, 2012

Record last verified: 2012-11

Locations

PL (1)