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

Cataract Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01726543
• Other study ID #: BW1 151/12
• Secondary ID: BW1151/12
• Status: Recruiting
• Phase: N/A
• First received: April 17, 2012
• Last updated: November 10, 2012
• Start date: February 2011
• Est. completion date: December 2014

Study information

• Verified date: November 2012
• Source: Military Institute of Medicine, Poland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 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
• Open Angle Glaucoma

Intervention

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.
• Non-penetrating deep sclerectomy and phacoemulsification
A fornix-based conjunctival ?ap is dissected superiorly, and the sclera is exposed. A 5 x 5 mm scleral ?ap 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 ?ap 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 ?ap 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.

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	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	No
Primary	number of antiglaucoma medications		Change from Baseline at 24months	No
Primary	visual acuity	ETDRS chart	Change from Baseline at 24months	No
Primary	intraoperative complications	Rates for surgical complications and adverse events	surgery day	Yes
Secondary	Secondary procedures	Any additional ophtalmic surgical procedures that need to be done within the time frame.	within 24 months	Yes
Secondary	Early and late complications	complications and Adverse effects rate	within 24 months	Yes