Steroid Induced GlaucomaPhase 1/2NCT01912638
Trabeculectomy With Ologen Collagen Implant vs Trabeculectomy With Provisc in Steroid Induced Glaucoma
A Phase 1/2 study testing Ologen Collagen Matrix and Provisc in people with Steroid Induced Glaucoma, run by National Centre of Ophthalmology named after academician Zarifa Aliyeva at 1 site in Azerbaijan.
Trial summary
The purpose of this prospective randomized study is to assess and compare the clinical efficacy and safety of primary trabeculectomy with Ologen® collagen implant and cohesive viscoelastic (Provisc®) - augmented trabeculectomy in patients with medically uncontrolled steroid induced glaucoma. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Steroid Induced Glaucoma
- What is being tested?
- Ologen Collagen Matrix and Provisc
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteAzerbaijan
- Study dates
- Jul 2012to Sep 2016
- Phase
- Phase 1/2
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age > 16 years (inclusive)
- Patients with medically uncontrolled steroid induced glaucoma
Who cannot join
- Primary open angle glaucoma, angle-closure glaucoma, post-traumatic, uveitic, neovascular, or dysgenetic glaucoma
- Known allergic reaction to porcine collagen
- Preliminary conjunctival damage (trauma, vitreo-retinal surgery, previous glaucoma or strabismus surgery, etc)
Trial locations and contacts
1 site in 1 country.
Azerbaijan1 site
National Centre of Ophthalmology named after academician Zarifa Aliyeva
Baku, AZ1114
About this study
Official title: Comparative Study of the Efficacy and Safety of Ologen Collagen Implant Versus Cohesive Viscoelastic in Trabeculectomy Performed for Steroid Induced Glaucoma
The purpose of this prospective randomized study is to assess and compare the clinical efficacy and safety of primary trabeculectomy with Ologen® collagen implant and cohesive viscoelastic (Provisc®) - augmented trabeculectomy in patients with medically uncontrolled steroid induced glaucoma.
Read the detailed description
Steroid induced glaucoma is a well known and widely described disastrous clinical condition. However the subject of selection of most effective and safe treatment modality is still being discussed.
Sihota R et al reported that 26.5% cases required surgical treatment to control IOP. Unfortunately survival rate of successful blebs in 10 years after trabeculectomy varies from 40% to 60%. Anti-fibrotic agent MMC as adjunct to filtration surgery was used to prevent postoperative scarring that could compromise surgical success of trabeculectomy. Additional use of MMC in trabeculectomy leads to low final IOP but could be associated with such complications as cataract formation, intraocular toxicity, avascular filtering blebs, wound leakage, subsequent blebitis and endophthalmitis. Tissue-engineered biodegradable and biocompatible implant Ologen® Collagen Matrix may be used as an alternative to MMC. Ologen® is CE Mark and FDA approved artificial porcine extracellular matrix for modulating wound healing. Ologen® has been tested in animal models and has triple action:
- prevent the collapse of the subconjunctival space;
- guides the fibroblast to grow through the matrix pores thus preventing scar formation;
- may act as an aqueous reservoir (avoids post-op hyperfiltration and shallow anterior chamber).
The filtering blebs scoring was performed by using Moorfields Bleb Grading System and Visante anterior segment optical coherence tomography.
- Conditions
- Steroid Induced Glaucoma
- Being tested
- Ologen Collagen Matrix, Provisc
- Keywords
- Trabeculectomy, Glaucoma, Steroids, Ologen, Viscoelastic
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ologen Collagen MatrixDevice
Ologen is a porous collagen-glycosaminoglycan matrix that decrease early postoperative scarring after penetrating anti-glaucomatous surgery by randomized collagen deposition and microcyst formation. Implantation of Ologen Collagen Matrix in trabeculectomy was performed.
ProviscDrug
Provisc is an cohesive viscoelastic.
| Study group | Role | What they receive |
|---|---|---|
| Implantation of Ologen in trabeculectomy | Experimental | Ologen Collagen Matrix is implanted in primary limbal-based trabeculectomy. It should be placed on the top of the loosely-sutured scleral flap before suturing of the conjunctiva thus preventing the collapse of the subconjunctival space. Receives: Device: Ologen Collagen Matrix |
| Provisc in trabeculectomy | Active comparator | Provisc is used in primary limbal-based trabeculectomy. At the end of the surgery cohesive viscoelastic (Provisc) is injected under the scleral flap to prevent early hypotony. Receives: Drug: Provisc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure (IOP)
The absolute success was defined as an IOP less than 21 mmHg with no glaucoma medications.
Follow-up visits were and will arranged at 1 and 2 first weeks, then every month during first 6 months, then every 3 months during 2.5 years after surgery.
Measured: 2 years
Secondary outcomes (3)
Postoperative complications
Complications were defined as follows: hypotony,shallow anterior chamber,serous or hemorrhagic choroidal detachment, hyphema,anterior chamber inflammation,persistent hypotonus maculopathy,corneal epithelial toxicity, "snuff" syndrome,blebitis or endophthalmitis,formation of Tenon's cyst.
Measured: 2 years
Corrected distance visual acuity (CDVA)
Measured: 2 years
Appearance of the filtering bleb (FB)
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 posted31 Jul 2013 (estimated)
- Study startJul 2012
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Steroid Induced GlaucomaStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Centre of Ophthalmology named after academician Zarifa Aliyeva
- Sponsor type
- Other government
- Collaborators
- Aeon Astron Europe B.V.
- Responsible party
- Sponsor
- Investigators
- Elmar Kasimov, Professor, Study director, Director of National Centre of OphthalmologyFidan Aghayeva, MD, Principal investigator, Glaucoma consultant at National Centre of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912638
- Sponsor's protocol ID
- Trab-Olo-SG
- Status last verified
- Jul 2015
- First submitted
- 29 Jul 2013
- Last updated
- 21 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Park J, Rittiphairoj T, Wang X, E JY, Bicket AK. Device-modified trabeculectomy for glaucoma. Cochrane Database Syst Rev. 2023 Mar 13;3(3):CD010472. doi: 10.1002/14651858.CD010472.pub3.
PubMed 36912740
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Efficacy and Safety of Ologen Collagen Implant Versus Cohesive Viscoelastic in Trabeculectomy Performed for Steroid Induced Glaucoma
- ClinicalTrials.gov ID
- NCT01912638
- Acronym / sponsor ID
- Trab-Olo-SG
- Conditions
- Steroid Induced Glaucoma
- Keywords
- Trabeculectomy, Glaucoma, Steroids, Ologen, Viscoelastic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- National Centre of Ophthalmology named after academician Zarifa AliyevaOther government
- Collaborators
- Aeon Astron Europe B.V.
- Study start
- Jul 2012
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 31 Jul 2013 (estimated)
- 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.
The purpose of this prospective randomized study is to assess and compare the clinical efficacy and safety of primary trabeculectomy with Ologen® collagen implant and cohesive viscoelastic (Provisc®) - augmented trabeculectomy in patients with medically uncontrolled steroid induced glaucoma.
Detailed description
Steroid induced glaucoma is a well known and widely described disastrous clinical condition. However the subject of selection of most effective and safe treatment modality is still being discussed.
Sihota R et al reported that 26.5% cases required surgical treatment to control IOP. Unfortunately survival rate of successful blebs in 10 years after trabeculectomy varies from 40% to 60%. Anti-fibrotic agent MMC as adjunct to filtration surgery was used to prevent postoperative scarring that could compromise surgical success of trabeculectomy. Additional use of MMC in trabeculectomy leads to low final IOP but could be associated with such complications as cataract formation, intraocular toxicity, avascular filtering blebs, wound leakage, subsequent blebitis and endophthalmitis. Tissue-engineered biodegradable and biocompatible implant Ologen® Collagen Matrix may be used as an alternative to MMC. Ologen® is CE Mark and FDA approved artificial porcine extracellular matrix for modulating wound healing. Ologen® has been tested in animal models and has triple action:
- prevent the collapse of the subconjunctival space;
- guides the fibroblast to grow through the matrix pores thus preventing scar formation;
- may act as an aqueous reservoir (avoids post-op hyperfiltration and shallow anterior chamber).
The filtering blebs scoring was performed by using Moorfields Bleb Grading System and Visante anterior segment optical coherence tomography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Implantation of Ologen in trabeculectomy | Experimental | Device: Ologen Collagen MatrixOlogen Collagen Matrix is implanted in primary limbal-based trabeculectomy. It should be placed on the top of the loosely-sutured scleral flap before suturing of the conjunctiva thus preventing the collapse of the subconjunctival space. |
| Provisc in trabeculectomy | Active comparator | Drug: ProviscProvisc is used in primary limbal-based trabeculectomy. At the end of the surgery cohesive viscoelastic (Provisc) is injected under the scleral flap to prevent early hypotony. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 16 years (inclusive)
- Patients with medically uncontrolled steroid induced glaucoma
Key exclusion criteria (3 listed)
- Primary open angle glaucoma, angle-closure glaucoma, post-traumatic, uveitic, neovascular, or dysgenetic glaucoma
- Known allergic reaction to porcine collagen
- Preliminary conjunctival damage (trauma, vitreo-retinal surgery, previous glaucoma or strabismus surgery, etc)
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 |
|---|---|---|
| Ologen Collagen MatrixOlogen is a porous collagen-glycosaminoglycan matrix that decrease early postoperative scarring after penetrating anti-glaucomatous surgery by randomized collagen deposition and microcyst formation. Implantation of Ologen Collagen Matrix in trabeculectomy was performed. | Device | Implantation of Ologen in trabeculectomy |
| ProviscProvisc is an cohesive viscoelastic. | Drug | Provisc in trabeculectomy |
Primary outcome
Intraocular Pressure (IOP)
Time frame: 2 years
The absolute success was defined as an IOP less than 21 mmHg with no glaucoma medications. Follow-up visits were and will arranged at 1 and 2 first weeks, then every month during first 6 months, then every 3 months during 2.5 years after surgery.
3 secondary outcomes
Postoperative complications
Time frame: 2 years
Corrected distance visual acuity (CDVA)
Time frame: 2 years
Appearance of the filtering bleb (FB)
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 21 Sep 2016.
- Derived from this study: PubMed 36912740Park J, Rittiphairoj T, Wang X, E JY, Bicket AK. Device-modified trabeculectomy for glaucoma. Cochrane Database Syst Rev. 2023 Mar 13;3(3):CD010472. doi: 10.1002/14651858.CD010472.pub3.
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.
Elmar Kasimov, Professor study director
Director of National Centre of Ophthalmology
Fidan Aghayeva, MD principal investigator
Glaucoma consultant at National Centre of Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ologen Collagen Matrix and Provisc in people with Steroid Induced Glaucoma, run by National Centre of Ophthalmology named after academician Zarifa Aliyeva at 1 site in Azerbaijan.
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 2 inclusion and 3 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 21 Sep 2016. 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 Azerbaijan. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Intraocular Pressure (IOP) (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 NCT01912638, which also lists 1 linked publication.
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 21 Sep 2016.