Outcomes of Trabeculectomy With MMCNCT03293251
Trabeculectomy With MMC and I Stent in Uveitic Glaucoma and POAG : Outcomes and Prognostic Factors
An observational study of Outcomes of Trabeculectomy With MMC, run by Assiut University at 1 site in Egypt.
Trial summary
1. determine whether cataract surgery has a major effect on outcomes of trabeculectomy with MMC or not. 2. Success rates of trabeculectomy with MMC in Queen Elizabeth hospital. 3. recurrence rate of uveitis after glaucoma surgery Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Outcomes of Trabeculectomy With MMC
- What is being tested?
- Trabeculectomy with MMC
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2017to 29 Dec 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: cohort of patient documented on the database system of Queen Elizabeth hospital
Who may be able to join
- Fesh trabeculectomy surgeries
Who cannot join
- recurrent surgeries
Trial locations and contacts
1 site in 1 country.
About this study
- determine whether cataract surgery has a major effect on outcomes of trabeculectomy with MMC or not.
- Success rates of trabeculectomy with MMC in Queen Elizabeth hospital.
- recurrence rate of uveitis after glaucoma surgery
Read the detailed description
- determine different success rates of trabeculectomy with MMC undergone in QE hospital, UK.
- determine different complications and effect of cataract surgery on the outcome of glaucoma surgery
- Conditions
- Outcomes of Trabeculectomy With MMC
- Being tested
- Trabeculectomy with MMC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trabeculectomy with MMCProcedure or surgery
Also called I-STENT
glaucoma surgeries
| Study group | Role | What they receive |
|---|---|---|
| uveitic/ POAG | Outcomes, success rates, complications of trabeculectomy with MMC in Uveitic glaucoma Receives: Procedure: Trabeculectomy with MMC | |
| POAG | Outcomes, success rates, complications of trabeculectomy with MMC and I stent in this groups Receives: Procedure: Trabeculectomy with MMC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rates
IOP less 21 mmHg
Measured: 5 year period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start1 Aug 2017
- Primary completion29 Oct 2018 (estimated)
- Study completion29 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Outcomes of Trabeculectomy With MMCStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Retrospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Collaborators
- The Queen Elizabeth Hospital
- Responsible party
- Principal investigator, Maha omar mahmoud said, Assiut University
- Investigators
- Dr Kamel Soliman, professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293251
- Sponsor's protocol ID
- 1111
- Status last verified
- Sep 2017
- First submitted
- 20 Sep 2017
- Last updated
- 26 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided yet
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trabeculectomy With MMC and I Stent in Uveitic Glaucoma and POAG : Outcomes and Prognostic Factors
- ClinicalTrials.gov ID
- NCT03293251
- Acronym / sponsor ID
- 1111
- Conditions
- Outcomes of Trabeculectomy With MMC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Collaborators
- The Queen Elizabeth Hospital
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 29 Oct 2018 (estimated)
- Study completion
- 29 Dec 2018 (estimated)
- First posted
- 26 Sep 2017 (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.
- determine whether cataract surgery has a major effect on outcomes of trabeculectomy with MMC or not.
- Success rates of trabeculectomy with MMC in Queen Elizabeth hospital.
- recurrence rate of uveitis after glaucoma surgery
Detailed description
- determine different success rates of trabeculectomy with MMC undergone in QE hospital, UK.
- determine different complications and effect of cataract surgery on the outcome of glaucoma surgery
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| uveitic/ POAG | – | Procedure: Trabeculectomy with MMCOutcomes, success rates, complications of trabeculectomy with MMC in Uveitic glaucoma |
| POAG | – | Procedure: Trabeculectomy with MMCOutcomes, success rates, complications of trabeculectomy with MMC and I stent in this groups |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- cohort of patient documented on the database system of Queen Elizabeth hospital
Key inclusion criteria (1 listed)
- Fesh trabeculectomy surgeries
Key exclusion criteria (1 listed)
- recurrent surgeries
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 |
|---|---|---|
| Trabeculectomy with MMCAlso: I-STENTglaucoma surgeries | Procedure or surgery | POAG, uveitic/ POAG |
Primary outcome
Success rates
Time frame: 5 year period
IOP less 21 mmHg
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2017.
- Individual participant dataSharing planned: Undecided. undecided yet
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.
Dr Kamel Soliman, professor study director
Assiut University
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 Outcomes of Trabeculectomy With MMC, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 1 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 26 Sep 2017. 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 Egypt. 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?
Results are not available in the source record.
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?
Success rates (time frame: 5 year period). 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 26 Sep 2017.