OCTAEarly Phase 1NCT04493073
Conjunctival Vascularity Changes Usnig OCTA After Trabeculectomy
A Early Phase 1 study testing Trabectulectomy, Mitomycin and Ologen Collagen Implant in people with OCTA, run by Asmaa Ahmed Ali Youssif.
Trial summary
Reduce the trauma and the time taken for patient rehabilitation. The prevailing trend is to perform a mitomycin- C (MMC)-augmented trabeculectomy and trabeculectomy with ologen implants in a trial to decrease bleb failure as a common post- trabeculectomy complication. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- OCTA
- What is being tested?
- Trabectulectomy, Mitomycin and Ologen Collagen Implant
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 1 Mar 2022
- Phase
- Early Phase 1
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients older than 18 years of age with primary or secondary open-angle glaucoma.
- Primary OAG (POAG) diagnosed on the basis of IOP measurements more than 21 mmHg, open angle on gonioscopy (Grade 3 or 4 on Schaffer grading system for angle width), glaucomatous visual field defects consistent with glaucomatous optic disc changes.
- PNAG was diagnosed by the presence of narrow or occludable angle on gonioscopy (Grade 2, or 1 on Schaffer grading system for angle width in at least 180° of the total circumference of the angle in primary position without indentation), glaucomatous optic disc changes, visual field defects and IOP more than 21 mmHg
Who cannot join
- pregnant or lactating female.
- previous intraocular surgery
- one-eyed patients.
- previous ocular trauma.
- uveitis-induced glaucoma, neovascular glaucoma, aphakic/pseudophakic glaucoma
- systemic connective tissue disease and missing more than 3 follow-up visits.
- Trabeculectomy augmented by either MMC or Ologen implant was indicated to study subjects if they had uncontrolled IOP under maximum antiglaucoma medications (3 antiglaucoma drugs) or due to poor socioeconomic status.
Trial locations and contacts
No sites are listed yet.
Khaled Abd El azzem, PhD contact
About this study
Official title: Comparison of Conjunctival Vascularity Changes Using Optical Coherence Tomography Angiography After Trabeculectomy With Mitomycin and Ologen Implants
- Reduce the trauma and the time taken for patient rehabilitation.
- The prevailing trend is to perform a mitomycin- C (MMC)-augmented trabeculectomy and trabeculectomy with ologen implants in a trial to decrease bleb failure as a common post- trabeculectomy complication.
- Is to develop a measurement protocol by OCT-A imaging and characterization of the bleb vascularity changes in glaucoma patients before and after surgery.
Read the detailed description
The main purpose of this project is to compare bleb vascularity changes using optical coherence tomography (OCT-A) between mitomycin- C (MMC)-augmented trabeculectomy and develop trabeculectomy with ologen implants to determine whether bleb vascularity measurements during preoperative and early postoperative periode could act as surrogate parameters to predict surgical outcomes.
Glaucoma often existent in the elderly population. Measuremets of bleb vascularity beginning to become an essential part of the glaucoma specialist's clinical and operative took. As investigators continue to collect data both clinically and in the laboratory, these various imaging modalities will shepherd surgeons into a more precise and predicable era of glaucoma surgeries.
- Conditions
- OCTA
- Being tested
- Trabectulectomy, Mitomycin, Ologen Collagen Implant, Mitomycin-C Kyowa®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrabectulectomyProcedure or surgery
decrease IOP
MitomycinDrug
Also called ologen implants
Decrease bleb failure
Ologen Collagen ImplantDevice
Ologen Collagen Implant (Aeon Astron Europe, Netherlands)
Mitomycin-C Kyowa®Device
Mitomycin-C Kyowa® (Biochem Pharmaceutical Industries, India)
| Study group | Role | What they receive |
|---|---|---|
| Trabectulectomy with mitomycin | Active comparator | Mitomycin-C Kyowa® (Biochem Pharmaceutical Industries, India) 10 mg vial 2 mg/ml concentration Receives: Procedure: Trabectulectomy; Drug: Mitomycin; Device: Mitomycin-C Kyowa® |
| Trabectulectomy with Ologen implants | Active comparator | Ologen Collagen Implant (Aeon Astron Europe, Netherlands) - three-dimensional collagen- GAG implant >90% lyophilized porcine atelocollagen and <10% lyophilized porcine GAG 12 mm in diameter with 1 mm of thickness and 6 mm in diameter with 2 mm of thickness Receives: Procedure: Trabectulectomy; Device: Ologen Collagen Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
conjunctival vascularity changes
conjunctival vascularity changes using OCTA
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start1 Dec 2020 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Mar 2022 (estimated)
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 OCTAStudies 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asmaa Ahmed Ali Youssif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Asmaa Ahmed Ali Youssif, Assiut University
- Investigators
- Mohamed Saad, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04493073
- Sponsor's protocol ID
- OCTA after Trabeculectomy
- Status last verified
- Jul 2020
- First submitted
- 24 Jul 2020
- Last updated
- 30 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
He M, Wang W, Zhang X, Huang W. Ologen implant versus mitomycin C for trabeculectomy: a systematic review and meta-analysis. PLoS One. 2014 Jan 20;9(1):e85782. doi: 10.1371/journal.pone.0085782. eCollection 2014.
PubMed 24465704
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Conjunctival Vascularity Changes Using Optical Coherence Tomography Angiography After Trabeculectomy With Mitomycin and Ologen Implants
- ClinicalTrials.gov ID
- NCT04493073
- Acronym / sponsor ID
- OCTA after Trabeculectomy
- Conditions
- OCTA
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Asmaa Ahmed Ali YoussifUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 30 Jul 2020 (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.
- Reduce the trauma and the time taken for patient rehabilitation.
- The prevailing trend is to perform a mitomycin- C (MMC)-augmented trabeculectomy and trabeculectomy with ologen implants in a trial to decrease bleb failure as a common post- trabeculectomy complication.
- Is to develop a measurement protocol by OCT-A imaging and characterization of the bleb vascularity changes in glaucoma patients before and after surgery.
Detailed description
The main purpose of this project is to compare bleb vascularity changes using optical coherence tomography (OCT-A) between mitomycin- C (MMC)-augmented trabeculectomy and develop trabeculectomy with ologen implants to determine whether bleb vascularity measurements during preoperative and early postoperative periode could act as surrogate parameters to predict surgical outcomes.
Glaucoma often existent in the elderly population. Measuremets of bleb vascularity beginning to become an essential part of the glaucoma specialist's clinical and operative took. As investigators continue to collect data both clinically and in the laboratory, these various imaging modalities will shepherd surgeons into a more precise and predicable era of glaucoma surgeries.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trabectulectomy with mitomycin | Active comparator | Procedure: Trabectulectomy, Drug: Mitomycin, Device: Mitomycin-C Kyowa®Mitomycin-C Kyowa® (Biochem Pharmaceutical Industries, India) 10 mg vial 2 mg/ml concentration |
| Trabectulectomy with Ologen implants | Active comparator | Procedure: Trabectulectomy, Device: Ologen Collagen ImplantOlogen Collagen Implant (Aeon Astron Europe, Netherlands) - three-dimensional collagen- GAG implant >90% lyophilized porcine atelocollagen and <10% lyophilized porcine GAG 12 mm in diameter with 1 mm of thickness and 6 mm in diameter with 2 mm of thickness |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients older than 18 years of age with primary or secondary open-angle glaucoma.
- Primary OAG (POAG) diagnosed on the basis of IOP measurements more than 21 mmHg, open angle on gonioscopy (Grade 3 or 4 on Schaffer grading system for angle width), glaucomatous visual field defects consistent with glaucomatous optic disc changes.
- PNAG was diagnosed by the presence of narrow or occludable angle on gonioscopy (Grade 2, or 1 on Schaffer grading system for angle width in at least 180° of the total circumference of the angle in primary position without indentation), glaucomatous optic disc changes, visual field defects and IOP more than 21 mmHg
Key exclusion criteria (7 listed)
- pregnant or lactating female.
- previous intraocular surgery
- one-eyed patients.
- previous ocular trauma.
- uveitis-induced glaucoma, neovascular glaucoma, aphakic/pseudophakic 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 |
|---|---|---|
| Trabectulectomydecrease IOP | Procedure or surgery | Trabectulectomy with Ologen implants, Trabectulectomy with mitomycin |
| MitomycinAlso: ologen implantsDecrease bleb failure | Drug | Trabectulectomy with mitomycin |
| Ologen Collagen ImplantOlogen Collagen Implant (Aeon Astron Europe, Netherlands) | Device | Trabectulectomy with Ologen implants |
| Mitomycin-C Kyowa®Mitomycin-C Kyowa® (Biochem Pharmaceutical Industries, India) | Device | Trabectulectomy with mitomycin |
Primary outcome
conjunctival vascularity changes
Time frame: 1 year
conjunctival vascularity changes using OCTA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Background: PubMed 24465704He M, Wang W, Zhang X, Huang W. Ologen implant versus mitomycin C for trabeculectomy: a systematic review and meta-analysis. PLoS One. 2014 Jan 20;9(1):e85782. doi: 10.1371/journal.pone.0085782. eCollection 2014.
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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.
Khaled Abd El azzem, PhD contact
Mohamed Saad study director
Assiut University
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Trabectulectomy, Mitomycin and Ologen Collagen Implant in people with OCTA, run by Asmaa Ahmed Ali Youssif.
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 3 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: status not confirmed, as of the sponsor's last update on 30 Jul 2020. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asmaa Ali, PhD (01002475442, asmaaahmedali@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
conjunctival vascularity changes (time frame: 1 year). 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 NCT04493073, 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 30 Jul 2020.