NCT01726543

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

Comparison of Safety and Efficacy of Canaloplasty and Non-penetrating Deep Sclerectomy Combined With Phacoemulsification to Treat Glaucoma and Cataract. A Randomised, Prospective Study.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Military Institute od Medicine National Research Institute · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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 Then the microcatheter is withdrawn and suture is pulled into the canal.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.
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.

Timeline

• Start date: 2011-02-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2012-11-15
• Last updated: 2012-11-15

Locations

1 site across 1 country: Poland