Visco-ologen: Combined Viscocanalostomy, Phacoemulsification, OIogen Implant in Open Angle Glaucoma

Sponsor

Zagazig University (Other)

Overall Status

Completed

CT.gov ID

NCT03782051

Collaborator

(none)

Enrollment

Location

Arms

53.5

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Primary Open-angle Glaucoma	Procedure: combined phacoemulsification and viscocanalostomy Procedure: combined phacoemulsification and viscocanalostomy and ologen	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

81 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Combined Phacoemulsification and Viscocanalostomy With Ologen Implant Versus Combined Phacoemulsification and Viscocanalostomy

Actual Study Start Date :

Aug 1, 2013

Actual Primary Completion Date :

Jan 14, 2018

Actual Study Completion Date :

Jan 14, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Phacovisco group group had combined phacoemulsification and viscocanalostomy	Procedure: combined phacoemulsification and viscocanalostomy phacoemulsification with viscocanalostomy Other Names: phaco-visco-canalostomy
Active Comparator: OloPhacovisco group group had combined phacoemulsification and viscocanalostomy and Ologen	Procedure: combined phacoemulsification and viscocanalostomy and ologen phacoemulsification with viscocanalostomy with ologen Other Names: phaco-visco-canalostomy with ologen implant

Arm

Intervention/Treatment

Active Comparator: Phacovisco group

group had combined phacoemulsification and viscocanalostomy

Procedure: combined phacoemulsification and viscocanalostomy

phacoemulsification with viscocanalostomy

Other Names:

phaco-visco-canalostomy

Active Comparator: OloPhacovisco group

group had combined phacoemulsification and viscocanalostomy and Ologen

Procedure: combined phacoemulsification and viscocanalostomy and ologen

phacoemulsification with viscocanalostomy with ologen

Other Names:

phaco-visco-canalostomy with ologen implant

Outcome Measures

Primary Outcome Measures

the intraocular pressure [2 years]
measured by mmHg using Goldman applanatin tonometry

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.