Combined Viscocanalostomy, Phacoemulsification, OIogen Implant in Open Angle Glaucoma
NCT ID: NCT03782051
Last Updated: 2018-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
81 participants
INTERVENTIONAL
2013-08-01
2018-01-14
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Phacovisco group
group had combined phacoemulsification and viscocanalostomy
combined phacoemulsification and viscocanalostomy
phacoemulsification with viscocanalostomy
OloPhacovisco group
group had combined phacoemulsification and viscocanalostomy and Ologen
combined phacoemulsification and viscocanalostomy and ologen
phacoemulsification with viscocanalostomy with ologen
Interventions
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combined phacoemulsification and viscocanalostomy
phacoemulsification with viscocanalostomy
combined phacoemulsification and viscocanalostomy and ologen
phacoemulsification with viscocanalostomy with ologen
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
ALL
No
Sponsors
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Zagazig University
OTHER_GOV
Responsible Party
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Ahmed moamen
princibal investigator, lecturer of ophthalmology
Principal Investigators
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Ahmed AM Gad, MD
Role: PRINCIPAL_INVESTIGATOR
Zagazig University
Locations
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Alpha vision center
Zagazig, Al Sharkeya, Egypt
Countries
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References
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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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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1102108
Identifier Type: -
Identifier Source: org_study_id