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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02279472
Other study ID # SecondXHCSU
Secondary ID
Status Recruiting
Phase N/A
First received September 30, 2014
Last updated October 28, 2014
Start date October 2014
Est. completion date January 2015

Study information

Verified date October 2014
Source Second Xiangya Hospital of Central South University
Contact Haomin Luo, Ph.D student
Phone +86 13875830738
Email lhmqqpp@163.com
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date January 2015
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 80 Years
Eligibility 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:

1. Corneal macula and other corneal diseases, ocular surface disease or corneal edema

2. Iridocyclitis

3. Ocular trauma and intraocular operation history

4. No fixationFundus lesions such as diabetic retinopathy or retinal detachment

5. No fixation

6. Ocular or systemic application of cortical steroids -

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
Laserex Tango Nd:YAG, Ellex-SuperQ Medical, Australia
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.

Locations

Country Name City State
China The Second Xiangya Hospital of Central South University, Changsha Hunan

Sponsors (1)

Lead Sponsor Collaborator
Second Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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. Epub 2006 Dec 29. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in anterior chamber after LPI at 1 month 1month No
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