Safety and Efficacy of Three Variants of Canaloplasty With Phacoemulsification to Treat Glaucoma and Cataract
Comparison of Safety and Efficacy of Three Variants of Canaloplasty: Ab-externo, Ab-interno and Minicanaloplasty Combined With Phacoemulsification to Treat Glaucoma and Cataract. A Randomised, Prospective Study.
2 other identifiers
interventional
90
1 country
1
Brief Summary
It is a comparative study of Safety and Efficacy of Three Variants of Canaloplasty: ab-externo, ab-interno and minicanaloplasty. Combined With Phacoemulsification to Treat Glaucoma and Cataract. It is a Randomised, Prospective Study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 17, 2016
CompletedFirst Posted
Study publicly available on registry
September 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedSeptember 21, 2016
September 1, 2016
2.8 years
September 17, 2016
September 17, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
mean IOP
change form baseline at 24 months
Number of antiglaucoma drugs
change from baseline at 24 months
intraoperative complications
at the day of surgery
Secondary Outcomes (4)
Best-Corrected Visual Acuity
change from baseline at 24 months
Visual Field changes
change from baseline at 24 months
Early and Late postsurgical complications
within 24 months
% IOP reduction
change at 24 months from baseline
Study Arms (3)
canaloplasty ab externo and phacoemulsification
ACTIVE COMPARATORAs soon as the two scleral flaps: deep and superficial -similar to deep sclerectomy are dissected, the phacoemulsification with PCIOL insertion is performed. After excision of the deep flap the descemets window and ostia of Schlemm canal are created, the microcatheter is placed in the canal and guided for 360 degrees within the canal. Surgeon observes the location of beacon tip through sclera and injects the Healon GV. Then a suture is tied to the distal tip and the microcatheter is withdrawn. As it appears at the other ostium of canal the microcatheter it separated from the suture.Then suture loop is tightened to tension the trabecular meshwork. The superficial flap is sutured watertight to prevent bleb formation
canaloplasty ab interno and phacoemulsification
ACTIVE COMPARATORThis variant of canaloplasty spares conjunctival surface. First phacoemulsification and PCIOL placement is performed. The Schlemm's canal is reached through goniotomy through anterior chamber. Similarly microcatheter is inserted and viscodilatator applicated. The key difference, is that no tensioning suture is left after the catheter is withdrawn. phacoemulsification is performed.
minicanaloplasty and phacoemulsification
ACTIVE COMPARATORThe dissected conjunctival flap is of minimal size. The scleral flaps are sized: superficial flap 3x1mm, and deep flap: 1x1 mm- with no removal of the deep flap. Afterwards phacoemulsification part is performed. The microcatheterization and viscodilatation are conducted as in the traditional procedure.The conjunctiva is closed with one suture or coagulation
Interventions
Eligibility Criteria
You may qualify if:
- co-existing glaucoma and cataract
- glaucoma types: primary open angle glaucoma,
- eye with characteristic glaucoma changes (biomicroscopic,visual field)
- IOP over 21 mmHg after washout
- patients not tolerating antiglaucoma medications,
- patients with poor compliance
- progression in visual field
You may not qualify if:
- previous surgical glaucoma procedure
- previous cataract surgery
- BCVA under 0,004
- closed angle glaucoma secondary glaucoma (pseudoexfoliative, pigmentary)
- poorly controlled diabetes mellitus
- advanced AMD
- active inflammatory disease
- pregnancy
- mental disease or emotional instability general steroid therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Military Institute of Medicine
Warsaw, 04-141, Poland
Related Publications (1)
Danielewska ME, Kicinska AK, Placek MM, Lewczuk K, Rekas M. Changes in spectral parameters of corneal pulse following canaloplasty. Graefes Arch Clin Exp Ophthalmol. 2019 Nov;257(11):2449-2459. doi: 10.1007/s00417-019-04433-9. Epub 2019 Aug 3.
PMID: 31377849DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD Professor of Ophthalmology
Study Record Dates
First Submitted
September 17, 2016
First Posted
September 21, 2016
Study Start
February 1, 2016
Primary Completion
December 1, 2018
Study Completion
December 1, 2019
Last Updated
September 21, 2016
Record last verified: 2016-09