- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02279472
Optical Coherence Tomography Quantitative Analysis of Changes in Anterior Chamber After Laser Peripheral Lridotomy
October 28, 2014 updated by: Haomin Luo, Second Xiangya Hospital of Central South University
The purpose of this study is to analysis changes in anterior segment morphology after laser peripheral lrldotomy measured by optical coherence tomography, and to evaluate treatment effectiveness
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
In the study ,primary angle closure(PAC) and primary angle closure glaucoma (PACG) will be recruited.
Anterior segment optical coherence tomography images captured before and after laser peripheral iridotomy will be analysed to provide objective and reproducible quantification of anterior segment biometric parameters.The outcomes can provide useful information for clinical strategies in the treatment and management of pathology related to angle closure.
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Haomin Luo, Ph.D student
- Phone Number: +86 13875830738
- Email: lhmqqpp@163.com
Study Locations
-
-
Hunan
-
Changsha, Hunan, China, 410000
- Recruiting
- The Second Xiangya Hospital of Central South University,
-
Contact:
- Haomin Luo, Ph.D student
- Phone Number: +86 13875830738
- Email: lhmqqpp@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
28 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
1 .The gonioscopy or UBM examination has confirmed the diagnosis of PACS or PAC 2. Intraocular pressure within 10 to 21 mmHg ,C/D≤0.6 3. Visual field is normal or only show paracentral scotoma 4. Vision or corrected visual acuity ≥0.8 5. Refractive degree no more than 200D 6. Exclude other ocular and systemic diseases
-
Exclusion Criteria:
- Corneal macula and other corneal diseases, ocular surface disease or corneal edema
- Iridocyclitis
- Ocular trauma and intraocular operation history
- No fixationFundus lesions such as diabetic retinopathy or retinal detachment
- No fixation
- Ocular or systemic application of cortical steroids -
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: laser peripheral iridotomy
Laser peripheral iridotomy (LPI) is widely regarded as the first-line intervention for either acute or chronic types of angle-closure glaucoma in early stage ,which relieves pupil block and thus flattening the iris contour and widening the drainage angle,performd by Nd.YAG LASER
|
All the patients will be achieved with pilocarpine 1% for pupil constriction, laser peripheral iridotomy(LPI) is performed using the ophthalmic neodymium: yttrium aluminium garnet laser (Laserex Tango Nd:YAG, Ellex-SuperQ Medical, Australia) and an VOLK iridotomy contact lens.
After LPI, patients will be given topical prednisolone acetate 0.1% for 7 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in anterior chamber after LPI at 1 month
Time Frame: 1month
|
1month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Xuanchu Duan, Ph.D, Central South University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Memarzadeh F, Li Y, Chopra V, Varma R, Francis BA, Huang D. Anterior segment optical coherence tomography for imaging the anterior chamber after laser peripheral iridotomy. Am J Ophthalmol. 2007 May;143(5):877-9. doi: 10.1016/j.ajo.2006.11.055. Epub 2006 Dec 29.
- Lee KS, Sung KR, Shon K, Sun JH, Lee JR. Longitudinal changes in anterior segment parameters after laser peripheral iridotomy assessed by anterior segment optical coherence tomography. Invest Ophthalmol Vis Sci. 2013 May 3;54(5):3166-70. doi: 10.1167/iovs.13-11630.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Anticipated)
December 1, 2014
Study Completion (Anticipated)
January 1, 2015
Study Registration Dates
First Submitted
September 30, 2014
First Submitted That Met QC Criteria
October 28, 2014
First Posted (Estimate)
October 31, 2014
Study Record Updates
Last Update Posted (Estimate)
October 31, 2014
Last Update Submitted That Met QC Criteria
October 28, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SecondXHCSU
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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