Primary Open Angle Glaucoma, Cataract
Conditions
Keywords
open angle glaucoma, canaloplasty, migs, abic
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.
Interventions
PROCEDUREcanaloplasty and phacoemulsification
Sponsors
Military Institute od Medicine National Research Institute
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: 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Best-Corrected Visual Acuity | change from baseline at 24 months | — |
| % IOP reduction | change at 24 months from baseline | — |
| Visual Field changes | change from baseline at 24 months | MD, |
| Early and Late postsurgical complications | within 24 months | — |
Countries
Poland
Contacts
Primary ContactMarek Rękas, MD, PhD, Professor
Backup ContactAleksandra Kicińska, MD
Outcome results
None listed