Combined Viscocanalostomy, Phacoemulsification, OIogen Implant in Open Angle Glaucoma
- Conditions
- Primary Open-angle Glaucoma
- Interventions
- Procedure: combined phacoemulsification and viscocanalostomy and ologenProcedure: combined phacoemulsification and viscocanalostomy
- Registration Number
- NCT03782051
- Lead Sponsor
- Zagazig University
- Brief Summary
This prospective, interventional, randomized clinical study was done at Alpha Vision Center, Zagazig, Egypt. Patients with coexisting cataract and glaucoma were randomized to receive either phaco-viscocanalostomy (Phacovisco group) or phaco-viscocanalostomy with Ologen® implant (OloPhacovisco group) . Follow-up period was 2 years. Nd:YAG laser goniopuncture was done in cases where the intraocular pressure (IOP) was elevated above 21 mmHg after discontinuation of corticosteroid eye drops at any follow-up visit.
Our hypothesis is that using Ologen® implant as a spacer in the subscleral reservoir in phaco-viscocanalostomy reduces fibrosis and increase the success rate of this operation
- Detailed Description
Background: To study the efficacy of the biodegradable collagen implant Ologen® as an adjuvant in phaco-viscocanalostomy in patients with coexisting cataract and primary open angle glaucoma.
Methods: This prospective, interventional, randomized clinical study was done at Alpha Vision Center, Zagazig, Egypt. Patients with coexisting cataract and glaucoma were randomized to receive either phaco-viscocanalostomy (Phacovisco group) or phaco-viscocanalostomy with Ologen® implant (OloPhacovisco group). Follow-up period was 2 years. Nd:YAG laser goniopuncture was done in cases where the intraocular pressure (IOP) was elevated above 21 mmHg after discontinuation of corticosteroid eye drops at any follow-up visit.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 81
- the presence of significant cataract interfering with vision (visual acuity ≤ 0.5) in the presence POAG.
- if cataract was associated with uncontrolled glaucoma, (IOP > 21 mmHg despite maximally tolerated medical therapy)
- if the IOP was ≤ 21 mmHg with use of at least two antiglaucoma drugs with medication intolerance
- poor patient compliance
- patients could not attend medical supervision
- patients had visual field deterioration.
- closed-angle glaucoma
- other types of open angle glaucoma (OAG), e.g. pigmentary glaucoma, inflammatory glaucoma or neovascular glaucoma,
- previous ocular trauma or surgery
- lens subluxation
- any eye diseases affecting the vision, e.g. anterior uveitis
- if there was a large perforation of the Descemet's membrane with iris prolapse during surgery (cases with microperforation, which is defined as small perforation with no associated iris prolapse, occurring during surgery were not excluded) intraoperative complications that might affect the IOP, e.g. vitreous loss.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OloPhacovisco group combined phacoemulsification and viscocanalostomy and ologen group had combined phacoemulsification and viscocanalostomy and Ologen Phacovisco group combined phacoemulsification and viscocanalostomy group had combined phacoemulsification and viscocanalostomy
- Primary Outcome Measures
Name Time Method the intraocular pressure 2 years measured by mmHg using Goldman applanatin tonometry
- Secondary Outcome Measures
Name Time Method surgical complications 2 years number of surgical complications encountered
the use and results of Nd:YAG laser goniopuncture 2 years number of cases needed goniopuncture
visual acuity results 2 years visual acuity measured by decimal system
Trial Locations
- Locations (1)
Alpha vision center
🇪🇬Zagazig, Al Sharkeya, Egypt