Combined Phacoemulsification and Viscocanalostomy With Ologen Implant Versus Combined Phacoemulsification and Viscocanalostomy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Primary Open-angle Glaucoma
- Sponsor
- Zagazig University
- Enrollment
- 81
- Locations
- 1
- Primary Endpoint
- the intraocular pressure
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Ahmed moamen
princibal investigator, lecturer of ophthalmology
Zagazig University
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
the intraocular pressure
Time Frame: 2 years
measured by mmHg using Goldman applanatin tonometry
Secondary Outcomes
- surgical complications(2 years)
- the use and results of Nd:YAG laser goniopuncture(2 years)
- visual acuity results(2 years)