GlaucomaPhase 2NCT03506542
Phacotrabeculectomy With Collagen Matrix Implant (Ologen®) Versus Mitomycin C
A Phase 2 study testing Ologen, Phacotrabeculectomy and Mitomycin C in people with Glaucoma and Cataract, run by Medical University of Lublin.
Trial summary
1. Study objective: To assess the efficacy and safety of collagen matrix implant (Ologen®; OLO) in phacotrabeculectomy and to compare with mitomycin C (MMC) augmented phacotrabeculectomy. 2. Study Design: The study is designed as a prospective randomized trial. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Cataract, Wound Heal
- What is being tested?
- Ologen, Phacotrabeculectomy and Mitomycin C
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- 2 Jun 2014to 30 Mar 2017
- Phase
- Phase 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cataract
- Primary open angle glaucoma or pseudoexfoliation glaucoma with progression of visual field loss and/or uncontrolled intraocular pressure levels with medication
Who cannot join
- Difficulty in reading or speaking Polish
- Previous ocular surgery
- Pregnant and breastfeeding women
- Angle closure glaucoma
- Secondary glaucoma except pseudoexfoliation glaucoma
- Ocular diseases with excessive scarring
- Allergy to collagen or Mitomycin C
About this study
Official title: Phacotrabeculectomy With Collagen Matrix Implant (Ologen®) Versus Mitomycin C Augmented Phacotrabeculectomy: Clinical Results of a Prospective Randomized Trial
- Study objective: To assess the efficacy and safety of collagen matrix implant (Ologen®; OLO) in phacotrabeculectomy and to compare with mitomycin C (MMC) augmented phacotrabeculectomy.
- Study Design: The study is designed as a prospective randomized trial. Patient who meet the inclusion/exclusion criteria and sign the informed consent form will be included for this study.
- Follow-Up: This investigation is including 7 post-operative visits and follow-up within 12 months from the date of surgery. Patients should be seen at postoperative days 1, 7, 30, 90, 180, 270 and 360.
Read the detailed description
- Prospective randomized comparative study
- Patients with cataract and: primary open angle glaucoma (POAG) pseudoexfoliation (PEX) glaucoma (PEXG)
- Phacotrabeculectomy augmented with OLO or MMC
- Follow-up - 12 months
- Conditions
- Glaucoma, Cataract, Wound Heal
- Being tested
- Ologen, Phacotrabeculectomy, Mitomycin C
- Medical subject headings
- Glaucoma, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlogenDevice
Also called OLO
Ologen implant placed over scleral flap during the surgery to avoid usage of Mitomycin C
PhacotrabeculectomyProcedure or surgery
Also called surgery
Trabeculectomy with cataract extraction
Mitomycin CDrug
Also called MMC
Mitomycin C 0.3 mg/ml for 3 minutes during the surgery (standard procedure)
| Study group | Role | What they receive |
|---|---|---|
| Ologen (OLO) | Experimental | Ologen implant (model 830601) placed over scleral flap during phacotrabeculectomy Receives: Device: Ologen; Procedure: Phacotrabeculectomy |
| Mitomycin C (MMC) | Active comparator | Mitomycin C (MMC) 0.3 mg/ml for 3 minutes under the scleral flap during phacotrabeculectomy (standard procedure) Receives: Procedure: Phacotrabeculectomy; Drug: Mitomycin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean intraocular pressure (IOP) after the surgery
Decrease in IOP before and after the surgery
Measured: 12 months
Secondary outcomes (3)
Mean best corrected visual acuity (BCVA) (LogMAR)
Increase in best corrected visual acuity (BCVA) (LogMAR) before and after the surgery
Measured: 12 months
Evaluation of the filtering bleb in MBGS (Moorfields Bleb Grading System)
To compare filtrating blebs in two arms of the study
Measured: 12 months
Mean number of antiglaucoma medications
To compare the number of antiglaucoma medications in two arms of the study
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start2 Jun 2014
- Primary completion1 Mar 2016
- Study completion30 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are randomized and have phacotrabeculectomy augmented with either OLO (Ologen) or MMC (Mitomycin C).
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lublin
- Sponsor type
- University, hospital or other
- Collaborators
- Aeon Astron Europe B.V.
- Responsible party
- Principal investigator, Aleksandra Wlaz, Medical University of Lublin
- Investigators
- Tomasz Żarnowski, MD PhD Prof, Study chair, Ophthalmology Clinic, Medical University in Lublin, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506542
- Sponsor's protocol ID
- not required
- Status last verified
- Apr 2018
- First submitted
- 14 Apr 2018
- Last updated
- 25 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phacotrabeculectomy With Collagen Matrix Implant (Ologen®) Versus Mitomycin C Augmented Phacotrabeculectomy: Clinical Results of a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT03506542
- Acronym / sponsor ID
- not required
- Conditions
- Glaucoma, Cataract, Wound Heal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Medical University of LublinUniversity, hospital or other
- Collaborators
- Aeon Astron Europe B.V.
- Study start
- 2 Jun 2014 (actual)
- Primary completion
- 1 Mar 2016 (actual)
- Study completion
- 30 Mar 2017 (actual)
- First posted
- 24 Apr 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.
- Study objective: To assess the efficacy and safety of collagen matrix implant (Ologen®; OLO) in phacotrabeculectomy and to compare with mitomycin C (MMC) augmented phacotrabeculectomy.
- Study Design: The study is designed as a prospective randomized trial. Patient who meet the inclusion/exclusion criteria and sign the informed consent form will be included for this study.
- Follow-Up: This investigation is including 7 post-operative visits and follow-up within 12 months from the date of surgery. Patients should be seen at postoperative days 1, 7, 30, 90, 180, 270 and 360.
Detailed description
- Prospective randomized comparative study
- Patients with cataract and: primary open angle glaucoma (POAG) pseudoexfoliation (PEX) glaucoma (PEXG)
- Phacotrabeculectomy augmented with OLO or MMC
- Follow-up - 12 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients are randomized and have phacotrabeculectomy augmented with either OLO (Ologen) or MMC (Mitomycin C).
| Arm | Type | Receives |
|---|---|---|
| Ologen (OLO) | Experimental | Device: Ologen, Procedure: PhacotrabeculectomyOlogen implant (model 830601) placed over scleral flap during phacotrabeculectomy |
| Mitomycin C (MMC) | Active comparator | Procedure: Phacotrabeculectomy, Drug: Mitomycin CMitomycin C (MMC) 0.3 mg/ml for 3 minutes under the scleral flap during phacotrabeculectomy (standard procedure) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cataract
- Primary open angle glaucoma or pseudoexfoliation glaucoma with progression of visual field loss and/or uncontrolled intraocular pressure levels with medication
Key exclusion criteria (7 listed)
- Difficulty in reading or speaking Polish
- Previous ocular surgery
- Pregnant and breastfeeding women
- Angle closure glaucoma
- Secondary glaucoma except pseudoexfoliation glaucoma
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 |
|---|---|---|
| OlogenAlso: OLOOlogen implant placed over scleral flap during the surgery to avoid usage of Mitomycin C | Device | Ologen (OLO) |
| PhacotrabeculectomyAlso: surgeryTrabeculectomy with cataract extraction | Procedure or surgery | Mitomycin C (MMC), Ologen (OLO) |
| Mitomycin CAlso: MMCMitomycin C 0.3 mg/ml for 3 minutes during the surgery (standard procedure) | Drug | Mitomycin C (MMC) |
Primary outcome
Mean intraocular pressure (IOP) after the surgery
Time frame: 12 months
Decrease in IOP before and after the surgery
3 secondary outcomes
Mean best corrected visual acuity (BCVA) (LogMAR)
Time frame: 12 months
Evaluation of the filtering bleb in MBGS (Moorfields Bleb Grading System)
Time frame: 12 months
Mean number of antiglaucoma medications
Time frame: 12 months
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 25 Apr 2018.
Related trials for Glaucoma
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
AI-Assisted vs Conventional Teleglaucoma Referral
Glaucoma
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Recruiting
Automated Applanation Tonometry - Updated
Glaucoma, Glaucoma, Suspect
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
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.
Tomasz Żarnowski, MD PhD Prof study chair
Ophthalmology Clinic, Medical University in Lublin, Poland
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ologen, Phacotrabeculectomy and Mitomycin C in people with Glaucoma and Cataract, run by Medical University of Lublin.
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 7 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 25 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
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?
Mean intraocular pressure (IOP) after the surgery (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2018.