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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01726543
Enrollment
80
Registered
2012-11-15
Start date
2011-02-28
Completion date
2014-12-31
Last updated
2012-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Open Angle Glaucoma

Keywords

canaloplasty, non-penetrating deep sclerectomy, glaucoma, cataract, ophthalmology, glaucoma surgery

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.

Interventions

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 Then the microcatheter is withdrawn and suture is pulled into the canal.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

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.

Sponsors

Military Institute od Medicine National Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
IOPChange from Baseline at 24monthsby 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 medicationsChange from Baseline at 24months
visual acuityChange from Baseline at 24monthsETDRS chart
intraoperative complicationssurgery dayRates for surgical complications and adverse events

Secondary

MeasureTime frameDescription
Secondary procedureswithin 24 monthsAny additional ophtalmic surgical procedures that need to be done within the time frame.
Early and late complicationswithin 24 monthscomplications and Adverse effects rate

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026