Glaucoma Patients Scheduled for TrabeculectomyPhase 2NCT01297803
Comparison of Two Method Antimetabolites Application on Corneal Function in Trabeculectomy Surgery
A Phase 2 study testing Mitomycin_c in people with Glaucoma Patients Scheduled for Trabeculectomy, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
Application of antimetabolite agents such as mitomycin_c has improved trabeculectomy results and better control of intraocular pressure complications such as corneal endothelial cell loss. However, Mitomycin_c can be applied remain a concern before or after sclera flap dissection. Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Glaucoma Patients Scheduled for Trabeculectomy
- What is being tested?
- Mitomycin_c
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteIran
- Study dates
- Nov 2010to Dec 2011
- 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 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age Range between 18 to 80 years old
- Trabeculectomy to JOAC, POAG, CACG, PXF, pigment dispersion syndrome.
Who cannot join
- Secondary glaucoma (active uveitis, NVG, specific syndromes such as axenfeld rieger, Iridocorneal Endothelial syndrome, aniridia, peters, etc).
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Labbafinejad medical center
Tehran
shahin Yazdani, 00982122585952, labbafi@hotmail.com
shahin yazdani
About this study
Official title: Corneal Endothelial Cell Loss Following Trabeculectomy With mitomycin_c Application Before Versus After Sclera Flap Dissection
Application of antimetabolite agents such as mitomycin_c has improved trabeculectomy results and better control of intraocular pressure complications such as corneal endothelial cell loss. However, Mitomycin_c can be applied remain a concern before or after sclera flap dissection. Mitomycin_c application after sclera flap dissection probably increases corneal endothelial cell loss. This study compares Mitomycin_c application two methods: before and after sclera flap dissection with regard to success rate and complication. patients on base of Mitomycin_c application time (1-2-3) minutes will be match randomise in to two groups( before and after sclera flap dissection) corneal. Endothelial cell density, polymorphism, polymegathism and intraocular pressure before and one month, three months, six months after surgery will measured.
- Being tested
- Mitomycin_c
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitomycin_cDrug
0.02%.1,2,3,minutes match randomized in to two groups(before \&after scleral flap dissection
Mitomycin_cDrug
0.02%.1,2,3,minutes match randomized in to two groups(before \&after scleral flap dissection
| Study group | Role | What they receive |
|---|---|---|
| Mitomycin_c application before sclera flap dissection | Active comparator | Not described Receives: Drug: Mitomycin_c |
| Mitomycin_c application after sclera flapdissection | Active comparator | Not described Receives: Drug: Mitomycin_c |
What is being measured
The primary outcome is the main question the study is designed to answer.
corneal endothelial cell density
specular microscopy
Measured: six month
corneal endothelial cell polymorphism
specular microscopy
Measured: 6 months
corneal endothelial cell polymegathism
specular microscopy
Measured: 6 months
Secondary outcomes (1)
IOP (intra ocular pressure)
applanation tonometry
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2011 (estimated)
- Study startNov 2010
- Primary completionJun 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma Patients Scheduled for TrabeculectomyStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297803
- Sponsor's protocol ID
- 8772
- Status last verified
- Nov 2010
- First submitted
- 19 Jan 2011
- Last updated
- 17 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Endothelial Cell Loss Following Trabeculectomy With mitomycin_c Application Before Versus After Sclera Flap Dissection
- ClinicalTrials.gov ID
- NCT01297803
- Acronym / sponsor ID
- 8772
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 17 Feb 2011 (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.
Application of antimetabolite agents such as mitomycin_c has improved trabeculectomy results and better control of intraocular pressure complications such as corneal endothelial cell loss. However, Mitomycin_c can be applied remain a concern before or after sclera flap dissection. Mitomycin_c application after sclera flap dissection probably increases corneal endothelial cell loss. This study compares Mitomycin_c application two methods: before and after sclera flap dissection with regard to success rate and complication. patients on base of Mitomycin_c application time (1-2-3) minutes will be match randomise in to two groups( before and after sclera flap dissection) corneal. Endothelial cell density, polymorphism, polymegathism and intraocular pressure before and one month, three months, six months after surgery will measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mitomycin_c application before sclera flap dissection | Active comparator | Drug: Mitomycin_c |
| Mitomycin_c application after sclera flapdissection | Active comparator | Drug: Mitomycin_c |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Age Range between 18 to 80 years old
- Trabeculectomy to JOAC, POAG, CACG, PXF, pigment dispersion syndrome.
Key exclusion criteria (1 listed)
- Secondary glaucoma (active uveitis, NVG, specific syndromes such as axenfeld rieger, Iridocorneal Endothelial syndrome, aniridia, peters, etc).
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 |
|---|---|---|
| Mitomycin_c0.02%.1,2,3,minutes match randomized in to two groups(before \&after scleral flap dissection | Drug | Mitomycin_c application before sclera flap dissection |
| Mitomycin_c0.02%.1,2,3,minutes match randomized in to two groups(before \&after scleral flap dissection | Drug | Mitomycin_c application after sclera flapdissection |
Primary outcome
corneal endothelial cell density
Time frame: six month
specular microscopy
corneal endothelial cell polymorphism
Time frame: 6 months
specular microscopy
corneal endothelial cell polymegathism
Time frame: 6 months
specular microscopy
1 secondary outcome
IOP (intra ocular pressure)
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2011.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mitomycin_c in people with Glaucoma Patients Scheduled for Trabeculectomy, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 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 17 Feb 2011. 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 Iran. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
corneal endothelial cell density (time frame: six month). The study lists 3 primary outcomes in all. 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 17 Feb 2011.