Combined Viscocanalostomy, Phacoemulsification, OIogen Implant in Open Angle Glaucoma (Visco-ologen)
Combined Phacoemulsification and Viscocanalostomy With Ologen Implant Versus Combined Phacoemulsification and Viscocanalostomy
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
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Al Sharkeya
-
Zagazig, Al Sharkeya, Egypt, 44511
- Alpha vision center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Phacovisco group
group had combined phacoemulsification and viscocanalostomy
|
phacoemulsification with viscocanalostomy
Other Names:
|
|
ACTIVE_COMPARATOR: OloPhacovisco group
group had combined phacoemulsification and viscocanalostomy and Ologen
|
phacoemulsification with viscocanalostomy with ologen
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the intraocular pressure
Time Frame: 2 years
|
measured by mmHg using Goldman applanatin tonometry
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
surgical complications
Time Frame: 2 years
|
number of surgical complications encountered
|
2 years
|
|
the use and results of Nd:YAG laser goniopuncture
Time Frame: 2 years
|
number of cases needed goniopuncture
|
2 years
|
|
visual acuity results
Time Frame: 2 years
|
visual acuity measured by decimal system
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ahmed AM Gad, MD, zagazig University
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1102108
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.