Safety and Efficacy of Canaloplasty and Non-penetrating Deep Sclerectomy With Phacoemulsification to Treat Glaucoma and Cataract
|ClinicalTrials.gov Identifier: NCT01726543|
Recruitment Status : Unknown
Verified November 2012 by Marek Rekas, Military Institute of Medicine, Poland.
Recruitment status was: Recruiting
First Posted : November 15, 2012
Last Update Posted : November 15, 2012
|Condition or disease||Intervention/treatment||Phase|
|Open Angle Glaucoma Cataract||Procedure: Canaloplasty and phacoemulsification Procedure: Non-penetrating deep sclerectomy and phacoemulsification||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|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 :||February 2011|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2014|
|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 Then the microcatheter is withdrawn and suture is pulled into the canal.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.
- IOP [ Time Frame: 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 [ Time Frame: Change from Baseline at 24months ]
- visual acuity [ Time Frame: Change from Baseline at 24months ]ETDRS chart
- intraoperative complications [ Time Frame: surgery day ]Rates for surgical complications and adverse events
- Secondary procedures [ Time Frame: within 24 months ]Any additional ophtalmic surgical procedures that need to be done within the time frame.
- Early and late complications [ Time Frame: within 24 months ]complications and Adverse effects rate
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01726543
|Military Institute of Medicine||Recruiting|
|Warsaw, Poland, 04-141|
|Contact: Anna Byszewska, MD 500285890 ext +48 firstname.lastname@example.org|
|Contact: Marek Rekas, MD, PhD Associate Professor of 226816575 ext +48 email@example.com|
|Study Director:||Marek Rekas, MD,PhD,Professor||Military Institute of Medicine, Poland|