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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Military Institute of Medicine, Poland
Sponsor:
Information provided by (Responsible Party):
Marek Rekas, Military Institute of Medicine, Poland
ClinicalTrials.gov Identifier:
NCT01726543
First received: April 17, 2012
Last updated: November 10, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Open Angle Glaucoma
Cataract
Procedure: Canaloplasty and phacoemulsification
Procedure: Non-penetrating deep sclerectomy and phacoemulsification

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Safety and Efficacy of Canaloplasty and Non-penetrating Deep Sclerectomy Combined With Phacoemulsification to Treat Glaucoma and Cataract. A Randomised, Prospective Study.

Resource links provided by NLM:


Further study details as provided by Military Institute of Medicine, Poland:

Primary Outcome Measures:
  • IOP [ Time Frame: Change from Baseline at 24months ] [ Designated as safety issue: No ]

    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.


  • number of antiglaucoma medications [ Time Frame: Change from Baseline at 24months ] [ Designated as safety issue: No ]
  • visual acuity [ Time Frame: Change from Baseline at 24months ] [ Designated as safety issue: No ]
    ETDRS chart

  • intraoperative complications [ Time Frame: surgery day ] [ Designated as safety issue: Yes ]
    Rates for surgical complications and adverse events


Secondary Outcome Measures:
  • Secondary procedures [ Time Frame: within 24 months ] [ Designated as safety issue: Yes ]
    Any additional ophtalmic surgical procedures that need to be done within the time frame.

  • Early and late complications [ Time Frame: within 24 months ] [ Designated as safety issue: Yes ]
    complications and Adverse effects rate


Estimated Enrollment: 80
Study Start Date: February 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01726543

Locations
Poland
Military Institute of Medicine Recruiting
Warsaw, Poland, 04-141
Contact: Anna Byszewska, MD    500285890 ext +48    ania.byszewska@gmail.com   
Contact: Marek Rekas, MD, PhD Associate Professor of    226816575 ext +48    rekaspl@gmail.com   
Sponsors and Collaborators
Military Institute of Medicine, Poland
Investigators
Study Director: Marek Rekas, MD,PhD,Professor Military Institute of Medicine, Poland
  More Information

No publications provided

Responsible Party: Marek Rekas, MD, PhD Associate Professor of Ophthalmology, Military Institute of Medicine, Poland
ClinicalTrials.gov Identifier: NCT01726543     History of Changes
Other Study ID Numbers: BW1 151/12, BW1151/12
Study First Received: April 17, 2012
Last Updated: November 10, 2012
Health Authority: Poland: Ministry of Health

Keywords provided by Military Institute of Medicine, Poland:
canaloplasty
non-penetrating deep sclerectomy
glaucoma
cataract
ophthalmology
glaucoma surgery

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Cataract
Ocular Hypertension
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on August 19, 2014