Combined Viscocanalostomy, Phacoemulsification, OIogen Implant in Open Angle Glaucoma

NCT03782051 | Completed

• 1 other identifier: 1102108
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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

Conditions

Primary Open-angle Glaucoma

Keywords

Viscocanalostomy; Ologen; glaucoma; phacoemulsification

Outcome Measures

Primary Outcomes (1)

• the intraocular pressure

  measured by mmHg using Goldman applanatin tonometry

  2 years

Secondary Outcomes (3)

• surgical complications

  2 years

• the use and results of Nd:YAG laser goniopuncture

  2 years

• visual acuity results

  2 years

Study Arms (2)

Phacovisco group

ACTIVE COMPARATOR

group had combined phacoemulsification and viscocanalostomy

Procedure: combined phacoemulsification and viscocanalostomy

OloPhacovisco group

ACTIVE COMPARATOR

group had combined phacoemulsification and viscocanalostomy and Ologen

Procedure: combined phacoemulsification and viscocanalostomy and ologen

Interventions

combined phacoemulsification and viscocanalostomy PROCEDURE

phacoemulsification with viscocanalostomy

Also known as: phaco-visco-canalostomy

Phacovisco group

combined phacoemulsification and viscocanalostomy and ologen PROCEDURE

phacoemulsification with viscocanalostomy with ologen

Also known as: phaco-visco-canalostomy with ologen implant

OloPhacovisco group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Alpha vision center

Zagazig, Al Sharkeya, 44511, Egypt

Location

Related Publications (6)

• 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.

  PMID: 21921953 BACKGROUND

• 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.

  PMID: 23279607 BACKGROUND

• 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.

  PMID: 24240882 BACKGROUND

• 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.

  PMID: 18344761 BACKGROUND

• 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. doi: 10.1038/sj.eye.6701469.

  PMID: 15258610 BACKGROUND

• Gad AAM, Abdulhalim BH, Lotfy A, Abdelrahman AM, Ahmed AS. Combined phacoemulsification and viscocanalostomy with Ologen implant versus combined phacoemulsification and viscocanalostomy. BMC Ophthalmol. 2019 Feb 6;19(1):45. doi: 10.1186/s12886-019-1049-6.

  PMID: 30727982 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma

Interventions

collagen-glycosaminoglycan copolymer

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Ahmed AM Gad, MD

  Zagazig University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: princibal investigator, lecturer of ophthalmology

Study Record Dates

• First Submitted: December 16, 2018
• First Posted: December 20, 2018
• Study Start: August 1, 2013
• Primary Completion: January 14, 2018
• Study Completion: January 14, 2018
• Last Updated: December 20, 2018

Record last verified: 2018-12

Locations

EG (1)