Combined Viscocanalostomy, Phacoemulsification, OIogen Implant in Open Angle Glaucoma

Primary Open-angle Glaucoma Clinical Trial

— Visco-ologen  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03782051
• Other study ID #: 1102108
• Status: Completed
• Phase: N/A
• Start date: August 1, 2013
• Est. completion date: January 14, 2018

Study information

• Verified date: December 2018
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: January 14, 2018
• Est. primary completion date: January 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Primary Open-angle Glaucoma

Intervention

Procedure:
• combined phacoemulsification and viscocanalostomy
phacoemulsification with viscocanalostomy
• combined phacoemulsification and viscocanalostomy and ologen
phacoemulsification with viscocanalostomy with ologen

Locations

Country	Name	City	State
Egypt	Alpha vision center	Zagazig	Al Sharkeya

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

Cillino S, Di Pace F, Cillino G, Casuccio A. Biodegradable collagen matrix implant vs mitomycin-C as an adjuvant in trabeculectomy: a 24-month, randomized clinical trial. Eye (Lond). 2011 Dec;25(12):1598-606. doi: 10.1038/eye.2011.219. Epub 2011 Sep 16. — View Citation

Hondur A, Onol M, Hasanreisoglu B. Nonpenetrating glaucoma surgery: meta-analysis of recent results. J Glaucoma. 2008 Mar;17(2):139-46. doi: 10.1097/IJG.0b013e31814b98f7. — View Citation

Johnson MS, Sarkisian SR Jr. Using a collagen matrix implant (Ologen) versus mitomycin-C as a wound healing modulator in trabeculectomy with the Ex-PRESS mini glaucoma device: a 12-month retrospective review. J Glaucoma. 2014 Dec;23(9):649-52. doi: 10.1097/IJG.0000000000000018. — View Citation

Narayanaswamy A, Perera SA, Htoon HM, Hoh ST, Seah SK, Wong TT, Aung T. Efficacy and safety of collagen matrix implants in phacotrabeculectomy and comparison with mitomycin C augmented phacotrabeculectomy at 1 year. Clin Exp Ophthalmol. 2013 Aug;41(6):552-60. doi: 10.1111/ceo.12058. — View Citation

Shaarawy T, Mermoud A. Deep sclerectomy in one eye vs deep sclerectomy with collagen implant in the contralateral eye of the same patient: long-term follow-up. Eye (Lond). 2005 Mar;19(3):298-302. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the intraocular pressure	measured by mmHg using Goldman applanatin tonometry	2 years
Secondary	surgical complications	number of surgical complications encountered	2 years
Secondary	the use and results of Nd:YAG laser goniopuncture	number of cases needed goniopuncture	2 years
Secondary	visual acuity results	visual acuity measured by decimal system	2 years