GlaucomaNCT04552314
Bleb Vascularity and the Outcomes After Trabeculectomy
An observational study of Glaucoma and Filtering Bleb, run by Medical University of Lublin.
Trial summary
1. Study objective: To evaluate the relationship between filtering bleb vascularity and the surgical outcomes after trabeculectomy 2. Study design: A prospective study of 51 eyes of 44 patients after primary MMC-augmented trabeculectomy. The follow-up was 12 months. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Filtering Bleb
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Mar 2016
- Phase
- Observational
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with medically uncontrolled glaucoma who underwent primary trabeculectomy with mitomycin C (MMC) in the Department of Diagnostics and Microsurgery of Glaucoma of Medical University of Lublin, Poland
Who may be able to join
- primary open angle glaucoma (POAG) with medically uncontrolled intraocular pressure (IOP)
- pseudoexfoliation glaucoma (PEXG) with medically uncontrolled intraocular pressure (IOP)
Who cannot join
- primary angle closure glaucoma (PACG)
- secondary glaucoma except PEXG
- previous eye surgery
- subjects with decreased vision due to other reasons than glaucoma (e.g., exudative age-related macular degeneration (AMD), proliferative diabetic retinopathy, inflammatory eye diseases)
About this study
Official title: Predictive Value of Postoperative Filtering Bleb Vascularity in Mitomycin-C Augmented Trabeculectomy
- Study objective: To evaluate the relationship between filtering bleb vascularity and the surgical outcomes after trabeculectomy
- Study design: A prospective study of 51 eyes of 44 patients after primary MMC-augmented trabeculectomy. The follow-up was 12 months.
Read the detailed description
Total vessel area of a filtering bleb was measured with ImageJ software on colour photographs of a filtering bleb on day 1, 14, 1, 3 and 6 months and 1 year after trabeculectomy. Blebs were classified clinically as successful (IOP below 18 mmHg and a >30% reduction in IOP without antiglaucoma medications or additional surgical interventions) or failed. Linear regression analysis was performed to determine the correlation of the bleb vascularity with IOP.
- Conditions
- Glaucoma, Filtering Bleb
- Keywords
- filtering bleb, trabeculectomy, glaucoma
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients after primary MMC-augmented trabeculectomy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of surgical success
The successful bleb group consisted of eyes with IOP below 18 mmHg and a >30% reduction in IOP at 1 year after surgery without antiglaucoma medications or additional surgical interventions. Failed blebs were defined when IOP was over 18 mmHg, below 18 mmHg with antiglaucoma medications or if any additional surgical intervention was necessary
Measured: 1 year
Secondary outcomes (1)
Correlation of Bleb vascularity with IOP
Linear regression analysis was performed to determine the correlation of the bleb vascularity with IOP
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study startJul 2014
- Primary completionJul 2015
- Study completionMar 2016
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lublin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tomasz Żarnowski, MD, PhD, Professor, Study chair, Medical University in Lublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04552314
- Sponsor's protocol ID
- KE-0254/203/2014
- Status last verified
- Sep 2020
- First submitted
- 11 Sep 2020
- Last updated
- 30 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Postoperative Filtering Bleb Vascularity in Mitomycin-C Augmented Trabeculectomy
- ClinicalTrials.gov ID
- NCT04552314
- Acronym / sponsor ID
- KE-0254/203/2014
- Conditions
- Glaucoma, Filtering Bleb
- Keywords
- filtering bleb, trabeculectomy, glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Medical University of LublinUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 17 Sep 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.
- Study objective: To evaluate the relationship between filtering bleb vascularity and the surgical outcomes after trabeculectomy
- Study design: A prospective study of 51 eyes of 44 patients after primary MMC-augmented trabeculectomy. The follow-up was 12 months.
Detailed description
Total vessel area of a filtering bleb was measured with ImageJ software on colour photographs of a filtering bleb on day 1, 14, 1, 3 and 6 months and 1 year after trabeculectomy. Blebs were classified clinically as successful (IOP below 18 mmHg and a >30% reduction in IOP without antiglaucoma medications or additional surgical interventions) or failed. Linear regression analysis was performed to determine the correlation of the bleb vascularity with IOP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients after primary MMC-augmented trabeculectomy | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with medically uncontrolled glaucoma who underwent primary trabeculectomy with mitomycin C (MMC) in the Department of Diagnostics and Microsurgery of Glaucoma of Medical University of Lublin, Poland
Key inclusion criteria (2 listed)
- primary open angle glaucoma (POAG) with medically uncontrolled intraocular pressure (IOP)
- pseudoexfoliation glaucoma (PEXG) with medically uncontrolled intraocular pressure (IOP)
Key exclusion criteria (4 listed)
- primary angle closure glaucoma (PACG)
- secondary glaucoma except PEXG
- previous eye surgery
- subjects with decreased vision due to other reasons than glaucoma (e.g., exudative age-related macular degeneration (AMD), proliferative diabetic retinopathy, inflammatory eye diseases)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rates of surgical success
Time frame: 1 year
The successful bleb group consisted of eyes with IOP below 18 mmHg and a >30% reduction in IOP at 1 year after surgery without antiglaucoma medications or additional surgical interventions. Failed blebs were defined when IOP was over 18 mmHg, below 18 mmHg with antiglaucoma medications or if any additional surgical intervention was necessary
1 secondary outcome
Correlation of Bleb vascularity with IOP
Time frame: 6 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 30 Oct 2023.
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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.
Tomasz Żarnowski, MD, PhD, Professor study chair
Medical University in Lublin
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma and Filtering Bleb, 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 4 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 30 Oct 2023. 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.
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?
Rates of surgical success (time frame: 1 year). 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 30 Oct 2023.