Open-angle GlaucomaNCT02638181
The Expression of Matrix Metalloproteinase 13, Tissue Inhibitor of Metalloproteinases 3, and Calcium-sensing Receptor in Human Trabecular Meshwork
A study testing trabeculectomy in people with Open-angle Glaucoma, run by Lv Yingjuan at 1 site in China.
Trial summary
This study was to assess the distinct expression of matrix metalloproteinase 13,tissue inhibitor of metalloproteinases 3, and calcium-sensing receptor, in human trabecular meshwork between normal and glaucomatous eyes.The expressions of matrix metalloproteinase 13, tissue inhibitor of metalloproteinases 3 and… Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Open-angle Glaucoma
- What is being tested?
- trabeculectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jul 2013to Dec 2015
- Phase
- Interventional
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- intraocular pressure greater than 22 mmHg with two or more medications
- wide anterior chamber angle
- glaucomatous optic neuropathy (Glaucomatous optic nerve damage was defined as cup-to-disc ratio higher than 0.7 or focal loss of the nerve fiber layer (notch) associated with a consistent glaucomatous visual field defect
- visual field loss consistent with optic nerve damage and visual fields were performed by using standard automated perimetry
Who cannot join
- the presence of any secondary form of glaucoma including exfoliation syndrome or a history of ocular trauma, etc
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, 300384
About this study
Official title: The Expression of Matrix Metalloproteinase 13（MMP13）, Tissue Inhibitor of Metalloproteinases 3（TIMP13）, and Calcium-sensing Receptor（CaSR） in Human Trabecular Meshwork
This study was to assess the distinct expression of matrix metalloproteinase 13,tissue inhibitor of metalloproteinases 3, and calcium-sensing receptor, in human trabecular meshwork between normal and glaucomatous eyes.The expressions of matrix metalloproteinase 13, tissue inhibitor of metalloproteinases 3 and calcium-sensing receptor in the trabecular meshwork tissues were examined by streptavidin-peroxidase immunohistochemical staining method and western blot, and histological changes of trabecular meshwork were studied by Hematoxylin and Eosin staining.
- Conditions
- Open-angle Glaucoma
- Being tested
- trabeculectomy
- Keywords
- matrix metalloproteinase 13, tissue inhibitor of metalloproteinases 3, calcium-sensing receptor, trabecular meshwork, open-angle glaucoma
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trabeculectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| trabeculectomy | Experimental | Not described Receives: Procedure: trabeculectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the expressions of matrix metalloproteinase 13 and calcium-sensing receptor
Measured: one hour after operation
Secondary outcomes (1)
histological changes of trabecular meshwork
Measured: one hour after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2015 (estimated)
- Study startJul 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open-angle 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lv Yingjuan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lv Yingjuan, Tianjin Medical University Eye Hospital
- Investigators
- xiaorong li, Study director, Tianjin Medical University Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02638181
- Sponsor's protocol ID
- tjykdxykyy3
- Status last verified
- Jan 2017
- First submitted
- 14 Dec 2015
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Expression of Matrix Metalloproteinase 13（MMP13）, Tissue Inhibitor of Metalloproteinases 3（TIMP13）, and Calcium-sensing Receptor（CaSR） in Human Trabecular Meshwork
- ClinicalTrials.gov ID
- NCT02638181
- Acronym / sponsor ID
- tjykdxykyy3
- Conditions
- Open-angle Glaucoma
- Keywords
- matrix metalloproteinase 13, tissue inhibitor of metalloproteinases 3, calcium-sensing receptor, trabecular meshwork, open-angle glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Lv YingjuanUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 23 Dec 2015 (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.
This study was to assess the distinct expression of matrix metalloproteinase 13,tissue inhibitor of metalloproteinases 3, and calcium-sensing receptor, in human trabecular meshwork between normal and glaucomatous eyes.The expressions of matrix metalloproteinase 13, tissue inhibitor of metalloproteinases 3 and calcium-sensing receptor in the trabecular meshwork tissues were examined by streptavidin-peroxidase immunohistochemical staining method and western blot, and histological changes of trabecular meshwork were studied by Hematoxylin and Eosin staining.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| trabeculectomy | Experimental | Procedure: trabeculectomy |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- intraocular pressure greater than 22 mmHg with two or more medications
- wide anterior chamber angle
- glaucomatous optic neuropathy (Glaucomatous optic nerve damage was defined as cup-to-disc ratio higher than 0.7 or focal loss of the nerve fiber layer (notch) associated with a consistent glaucomatous visual field defect
- visual field loss consistent with optic nerve damage and visual fields were performed by using standard automated perimetry
Key exclusion criteria (1 listed)
- the presence of any secondary form of glaucoma including exfoliation syndrome or a history of ocular trauma, 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 |
|---|---|---|
| trabeculectomy | Procedure or surgery | trabeculectomy |
Primary outcome
the expressions of matrix metalloproteinase 13 and calcium-sensing receptor
Time frame: one hour after operation
1 secondary outcome
histological changes of trabecular meshwork
Time frame: one hour after operation
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 10 Jan 2017.
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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.
xiaorong li study director
Tianjin Medical University Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing trabeculectomy in people with Open-angle Glaucoma, run by Lv Yingjuan at 1 site in China.
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 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: finished, as of the sponsor's last update on 10 Jan 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 China. 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?
the expressions of matrix metalloproteinase 13 and calcium-sensing receptor (time frame: one hour after operation). 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 10 Jan 2017.