Safety and Efficacy of Canaloplasty and Non-penetrating Deep Sclerectomy With Phacoemulsification to Treat Glaucoma and Cataract
NCT ID: NCT01726543
Last Updated: 2012-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2011-02-28
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Canaloplasty and phacoemulsification
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 Then the microcatheter is withdrawn and suture is pulled into the canal.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
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.
Interventions
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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 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 Criteria
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Inclusion Criteria
* 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 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
21 Years
ALL
No
Sponsors
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Military Institute od Medicine National Research Institute
OTHER
Responsible Party
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Marek Rekas
MD, PhD Associate Professor of Ophthalmology
Principal Investigators
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Marek Rekas, MD,PhD,Professor
Role: STUDY_DIRECTOR
Military Institute od Medicine National Research Institute
Locations
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Military Institute of Medicine
Warsaw, , Poland
Countries
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Facility Contacts
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Anna Byszewska, MD
Role: primary
Marek Rekas, MD, PhD Associate Professor of
Role: backup
Other Identifiers
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BW1151/12
Identifier Type: OTHER
Identifier Source: secondary_id
BW1 151/12
Identifier Type: -
Identifier Source: org_study_id