Primary Open-angle Glaucoma
Conditions
Keywords
Viscocanalostomy, Ologen, glaucoma, phacoemulsification
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.
Interventions
PROCEDUREcombined phacoemulsification and viscocanalostomy
phacoemulsification with viscocanalostomy
PROCEDUREcombined phacoemulsification and viscocanalostomy and ologen
phacoemulsification with viscocanalostomy with ologen
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the intraocular pressure | 2 years | measured by mmHg using Goldman applanatin tonometry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Outcome results
None listed