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

Primary Purpose

Primary Open-angle Glaucoma

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
combined phacoemulsification and viscocanalostomy
combined phacoemulsification and viscocanalostomy and ologen
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open-angle Glaucoma focused on measuring Viscocanalostomy, Ologen, glaucoma, phacoemulsification

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Alpha vision center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Phacovisco group

OloPhacovisco group

Arm Description

group had combined phacoemulsification and viscocanalostomy

group had combined phacoemulsification and viscocanalostomy and Ologen

Outcomes

Primary Outcome Measures

the intraocular pressure
measured by mmHg using Goldman applanatin tonometry

Secondary Outcome Measures

surgical complications
number of surgical complications encountered
the use and results of Nd:YAG laser goniopuncture
number of cases needed goniopuncture
visual acuity results
visual acuity measured by decimal system

Full Information

First Posted
December 16, 2018
Last Updated
December 17, 2018
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT03782051
Brief Title
Combined Viscocanalostomy, Phacoemulsification, OIogen Implant in Open Angle Glaucoma
Acronym
Visco-ologen
Official Title
Combined Phacoemulsification and Viscocanalostomy With Ologen Implant Versus Combined Phacoemulsification and Viscocanalostomy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2013 (Actual)
Primary Completion Date
January 14, 2018 (Actual)
Study Completion Date
January 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open-angle Glaucoma
Keywords
Viscocanalostomy, Ologen, glaucoma, phacoemulsification

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phacovisco group
Arm Type
Active Comparator
Arm Description
group had combined phacoemulsification and viscocanalostomy
Arm Title
OloPhacovisco group
Arm Type
Active Comparator
Arm Description
group had combined phacoemulsification and viscocanalostomy and Ologen
Intervention Type
Procedure
Intervention Name(s)
combined phacoemulsification and viscocanalostomy
Other Intervention Name(s)
phaco-visco-canalostomy
Intervention Description
phacoemulsification with viscocanalostomy
Intervention Type
Procedure
Intervention Name(s)
combined phacoemulsification and viscocanalostomy and ologen
Other Intervention Name(s)
phaco-visco-canalostomy with ologen implant
Intervention Description
phacoemulsification with viscocanalostomy with ologen
Primary Outcome Measure Information:
Title
the intraocular pressure
Description
measured by mmHg using Goldman applanatin tonometry
Time Frame
2 years
Secondary Outcome Measure Information:
Title
surgical complications
Description
number of surgical complications encountered
Time Frame
2 years
Title
the use and results of Nd:YAG laser goniopuncture
Description
number of cases needed goniopuncture
Time Frame
2 years
Title
visual acuity results
Description
visual acuity measured by decimal system
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed AM Gad, MD
Organizational Affiliation
Zagazig University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alpha vision center
City
Zagazig
State/Province
Al Sharkeya
ZIP/Postal Code
44511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21921953
Citation
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.
Results Reference
background
PubMed Identifier
23279607
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.
Results Reference
background
PubMed Identifier
24240882
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.
Results Reference
background
PubMed Identifier
18344761
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.
Results Reference
background
PubMed Identifier
15258610
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. doi: 10.1038/sj.eye.6701469.
Results Reference
background
PubMed Identifier
30727982
Citation
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.
Results Reference
derived

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Combined Viscocanalostomy, Phacoemulsification, OIogen Implant in Open Angle Glaucoma

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