GlaucomaNCT01711190
Astigmatism Post-trabeculectomy
An observational study of Glaucoma, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The aim of this project: 1. Confirming the modification in corneal astigmatism after trabeculectomy with MMC and intracameral administration of bevacizumab. 2. Medium-term follow up (6 months) of the induced corneal astigmatism. 3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- trabeculectomy
- Type of treatment
- Surgery or procedure
- How many people
- 52 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2012to Dec 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients having a primary trabeculectomy between January and April 2012 for glaucoma that was not adequately controlled with maximal tolerated medical therapy and/or laser therapy.
Who may be able to join
- Primary open angle glaucoma
- Normal tension glaucoma
- Pseudoexfoliation glaucoma
- Pigment dispersion glaucoma
Who cannot join
- Patients who refuse to sign the informed consent.
- Patients with primary angle closure glaucoma (PACG).
- Patients younger than 18 years old.
- Other ocular diseases besides glaucoma.
- Significant corneal opacities.
- Refractive error more than + or -6.00 diopters.
Show all 9Show fewer
- Visual acuity less than 0.05
- Previous intra-ocular surgery (except cataract surgery more than six months preceding the trabeculectomy).
- Laser treatment for glaucoma within 6 months of the surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Trabeculectomy on Astigmatism.
The aim of this project:
- Confirming the modification in corneal astigmatism after trabeculectomy with MMC and intracameral administration of bevacizumab.
- Medium-term follow up (6 months) of the induced corneal astigmatism.
- Investigating correlations between postoperative astigmatism, particularly with the postoperative IOP.
- Conditions
- Glaucoma
- Being tested
- trabeculectomy
- Keywords
- glaucoma, trabeculectomy, astigmatism, intraocular pressure
- Medical subject headings
- Glaucoma, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trabeculectomyProcedure or surgery
Filtering surgery to reduce the intra-ocular pressure.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ocular cylinder and axis untill 6 months after trabeculectomy.
Comparing the change in corneal cylinder, axis and IOP before the operation and 1,3 and 6 months after the operation. We will compare these vectors by vector analyses.
Measured: pre-operative until 6 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2012 (estimated)
- Study startJan 2012
- Primary completionNov 2012
- Study completionDec 2012
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.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heleen Delbeke, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Heleen Delbeke, MD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01711190
- Sponsor's protocol ID
- S53708
- Status last verified
- Dec 2024
- First submitted
- 24 Feb 2012
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Trabeculectomy on Astigmatism.
- ClinicalTrials.gov ID
- NCT01711190
- Acronym / sponsor ID
- S53708
- Conditions
- Glaucoma
- Keywords
- glaucoma, trabeculectomy, astigmatism, intraocular pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 22 Oct 2012 (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 aim of this project:
- Confirming the modification in corneal astigmatism after trabeculectomy with MMC and intracameral administration of bevacizumab.
- Medium-term follow up (6 months) of the induced corneal astigmatism.
- Investigating correlations between postoperative astigmatism, particularly with the postoperative IOP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients having a primary trabeculectomy between January and April 2012 for glaucoma that was not adequately controlled with maximal tolerated medical therapy and/or laser therapy.
Key inclusion criteria (4 listed)
- Primary open angle glaucoma
- Normal tension glaucoma
- Pseudoexfoliation glaucoma
- Pigment dispersion glaucoma
Key exclusion criteria (9 listed)
- Patients who refuse to sign the informed consent.
- Patients with primary angle closure glaucoma (PACG).
- Patients younger than 18 years old.
- Other ocular diseases besides glaucoma.
- Significant corneal opacities.
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 |
|---|---|---|
| trabeculectomyFiltering surgery to reduce the intra-ocular pressure. | Procedure or surgery | – |
Primary outcome
Change in ocular cylinder and axis untill 6 months after trabeculectomy.
Time frame: pre-operative until 6 months post-operative
Comparing the change in corneal cylinder, axis and IOP before the operation and 1,3 and 6 months after the operation. We will compare these vectors by vector analyses.
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 2024.
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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.
Heleen Delbeke, MD principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 4 inclusion and 9 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 2024. 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 Belgium. 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?
Change in ocular cylinder and axis untill 6 months after trabeculectomy. (time frame: pre-operative until 6 months post-operative). 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 20 Dec 2024.