Primary Open-angle GlaucomaVisco-ologenNCT03782051
Combined Viscocanalostomy, Phacoemulsification, OIogen Implant in Open Angle Glaucoma
A study testing combined phacoemulsification and viscocanalostomy and combined phacoemulsification and viscocanalostomy and ologen in people with Primary Open-angle Glaucoma, run by Zagazig University at 1 site in Egypt.
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) . Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Primary Open-angle Glaucoma
- What is being tested?
- combined phacoemulsification and viscocanalostomy and combined phacoemulsification and viscocanalostomy and ologen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2013to 14 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Primary Open-angle Glaucoma
- Being tested
- combined phacoemulsification and viscocanalostomy, combined phacoemulsification and viscocanalostomy and ologen
- Keywords
- Viscocanalostomy, Ologen, glaucoma, phacoemulsification
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined phacoemulsification and viscocanalostomyProcedure or surgery
Also called phaco-visco-canalostomy
phacoemulsification with viscocanalostomy
combined phacoemulsification and viscocanalostomy and ologenProcedure or surgery
Also called phaco-visco-canalostomy with ologen implant
phacoemulsification with viscocanalostomy with ologen
| Study group | Role | What they receive |
|---|---|---|
| Phacovisco group | Active comparator | group had combined phacoemulsification and viscocanalostomy Receives: Procedure: combined phacoemulsification and viscocanalostomy |
| OloPhacovisco group | Active comparator | group had combined phacoemulsification and viscocanalostomy and Ologen Receives: Procedure: combined phacoemulsification and viscocanalostomy and ologen |
What is being measured
The primary outcome is the main question the study is designed to answer.
the intraocular pressure
measured by mmHg using Goldman applanatin tonometry
Measured: 2 years
Secondary outcomes (3)
surgical complications
number of surgical complications encountered
Measured: 2 years
the use and results of Nd:YAG laser goniopuncture
number of cases needed goniopuncture
Measured: 2 years
visual acuity results
visual acuity measured by decimal system
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start1 Aug 2013
- Primary completion14 Jan 2018
- Study completion14 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Primary Open-angle GlaucomaStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ahmed moamen, Zagazig University
- Investigators
- Ahmed AM Gad, MD, Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03782051
- Sponsor's protocol ID
- 1102108
- Acronym
- Visco-ologen
- Status last verified
- Dec 2018
- First submitted
- 16 Dec 2018
- Last updated
- 20 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 21921953Narayanaswamy 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.
PubMed 23279607Johnson 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.
PubMed 24240882Hondur 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.
PubMed 18344761Shaarawy 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.
PubMed 15258610Gad 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.
PubMed 30727982
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Phacoemulsification and Viscocanalostomy With Ologen Implant Versus Combined Phacoemulsification and Viscocanalostomy
- ClinicalTrials.gov ID
- NCT03782051
- Acronym / sponsor ID
- Visco-ologen / 1102108
- Conditions
- Primary Open-angle Glaucoma
- Keywords
- Viscocanalostomy, Ologen, glaucoma, phacoemulsification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Aug 2013 (actual)
- Primary completion
- 14 Jan 2018 (actual)
- Study completion
- 14 Jan 2018 (actual)
- First posted
- 20 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phacovisco group | Active comparator | Procedure: combined phacoemulsification and viscocanalostomygroup had combined phacoemulsification and viscocanalostomy |
| OloPhacovisco group | Active comparator | Procedure: combined phacoemulsification and viscocanalostomy and ologengroup had combined phacoemulsification and viscocanalostomy and Ologen |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| combined phacoemulsification and viscocanalostomyAlso: phaco-visco-canalostomyphacoemulsification with viscocanalostomy | Procedure or surgery | Phacovisco group |
| combined phacoemulsification and viscocanalostomy and ologenAlso: phaco-visco-canalostomy with ologen implantphacoemulsification with viscocanalostomy with ologen | Procedure or surgery | OloPhacovisco group |
Primary outcome
the intraocular pressure
Time frame: 2 years
measured by mmHg using Goldman applanatin tonometry
3 secondary outcomes
surgical complications
Time frame: 2 years
the use and results of Nd:YAG laser goniopuncture
Time frame: 2 years
visual acuity results
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2018.
- Background: PubMed 21921953Cillino 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.
- Background: PubMed 23279607Narayanaswamy 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.
- Background: PubMed 24240882Johnson 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.
- Background: PubMed 18344761Hondur 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.
- Background: PubMed 15258610Shaarawy 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.
- Derived from this study: PubMed 30727982Gad 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed AM Gad, MD principal investigator
Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combined phacoemulsification and viscocanalostomy and combined phacoemulsification and viscocanalostomy and ologen in people with Primary Open-angle Glaucoma, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the intraocular pressure (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03782051, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2018.