Safety and Efficacy of Canaloplasty and Non-penetrating Deep Sclerectomy With Phacoemulsification to Treat Glaucoma and Cataract
Primary Purpose
Open Angle Glaucoma, Cataract
Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Canaloplasty and phacoemulsification
Non-penetrating deep sclerectomy and phacoemulsification
Sponsored by
About this trial
This is an interventional treatment trial for Open Angle Glaucoma focused on measuring canaloplasty, non-penetrating deep sclerectomy, glaucoma, cataract, ophthalmology, glaucoma surgery
Eligibility Criteria
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
Sites / Locations
- Military Institute of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Canaloplasty and phacoemulsification
Non-penetrating deep sclerectomy and phacoemulsification
Arm Description
Outcomes
Primary Outcome Measures
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.
number of antiglaucoma medications
visual acuity
ETDRS chart
intraoperative complications
Rates for surgical complications and adverse events
Secondary Outcome Measures
Secondary procedures
Any additional ophtalmic surgical procedures that need to be done within the time frame.
Early and late complications
complications and Adverse effects rate
Full Information
NCT ID
NCT01726543
First Posted
April 17, 2012
Last Updated
November 10, 2012
Sponsor
Military Institute od Medicine National Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01726543
Brief Title
Safety and Efficacy of Canaloplasty and Non-penetrating Deep Sclerectomy With Phacoemulsification to Treat Glaucoma and Cataract
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 Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Military Institute od Medicine National Research Institute
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Angle Glaucoma, Cataract
Keywords
canaloplasty, non-penetrating deep sclerectomy, glaucoma, cataract, ophthalmology, glaucoma surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Canaloplasty and phacoemulsification
Arm Type
Active Comparator
Arm Title
Non-penetrating deep sclerectomy and phacoemulsification
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Canaloplasty and phacoemulsification
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Non-penetrating deep sclerectomy and phacoemulsification
Intervention Description
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.
Primary Outcome Measure Information:
Title
IOP
Description
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.
Time Frame
Change from Baseline at 24months
Title
number of antiglaucoma medications
Time Frame
Change from Baseline at 24months
Title
visual acuity
Description
ETDRS chart
Time Frame
Change from Baseline at 24months
Title
intraoperative complications
Description
Rates for surgical complications and adverse events
Time Frame
surgery day
Secondary Outcome Measure Information:
Title
Secondary procedures
Description
Any additional ophtalmic surgical procedures that need to be done within the time frame.
Time Frame
within 24 months
Title
Early and late complications
Description
complications and Adverse effects rate
Time Frame
within 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marek Rekas, MD,PhD,Professor
Organizational Affiliation
Military Institute od Medicine National Research Institute
Official's Role
Study Director
Facility Information:
Facility Name
Military Institute of Medicine
City
Warsaw
ZIP/Postal Code
04-141
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Byszewska, MD
Phone
500285890
Ext
+48
Email
ania.byszewska@gmail.com
First Name & Middle Initial & Last Name & Degree
Marek Rekas, MD, PhD Associate Professor of
Phone
226816575
Ext
+48
Email
rekaspl@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Canaloplasty and Non-penetrating Deep Sclerectomy With Phacoemulsification to Treat Glaucoma and Cataract
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