Combined Viscocanalostomy, Phacoemulsification, OIogen Implant in Open Angle Glaucoma

N/ACompletedNCT03782051

Zagazig University81 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Primary Open-angle Glaucoma

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

measured by mmHg using Goldman applanatin tonometry

Time frame: 2 years

Secondary Outcomes

surgical complications

number of surgical complications encountered

Time frame: 2 years

the use and results of Nd:YAG laser goniopuncture

number of cases needed goniopuncture

Time frame: 2 years

visual acuity results

visual acuity measured by decimal system

Time frame: 2 years

Combined Viscocanalostomy, Phacoemulsification, OIogen Implant in Open Angle Glaucoma

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes