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

Sponsor

Military Institute of Medicine, Poland (Other)

Overall Status

Unknown status

CT.gov ID

NCT01726543

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Open Angle Glaucoma Cataract	Procedure: Canaloplasty and phacoemulsification Procedure: Non-penetrating deep sclerectomy and phacoemulsification	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (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.

Study Start Date :

Feb 1, 2011

Anticipated Primary Completion Date :

Dec 1, 2014

Anticipated Study Completion Date :

Dec 1, 2014

Arms and Interventions

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 Then the microcatheter is withdrawn and suture is pulled into the canal.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

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.

Outcome Measures

Primary Outcome Measures

IOP [Change from Baseline at 24months]
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 [Change from Baseline at 24months]
visual acuity [Change from Baseline at 24months]
ETDRS chart
intraoperative complications [surgery day]
Rates for surgical complications and adverse events

Secondary Outcome Measures

Secondary procedures [within 24 months]
Any additional ophtalmic surgical procedures that need to be done within the time frame.
Early and late complications [within 24 months]
complications and Adverse effects rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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