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Optical Coherence Tomography Quantitative Analysis of Changes in Anterior Chamber After Laser Peripheral Lridotomy

Primary Purpose

Primary Angle Closure Glaucoma

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Laserex Tango Nd:YAG, Ellex-SuperQ Medical, Australia
Sponsored by
Second Xiangya Hospital of Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Angle Closure Glaucoma

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

  • The Second Xiangya Hospital of Central South University,Recruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

laser peripheral iridotomy

Arm Description

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

Outcomes

Primary Outcome Measures

Changes in anterior chamber after LPI at 1 month

Secondary Outcome Measures

Full Information

First Posted
September 30, 2014
Last Updated
October 28, 2014
Sponsor
Second Xiangya Hospital of Central South University
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1. Study Identification

Unique Protocol Identification Number
NCT02279472
Brief Title
Optical Coherence Tomography Quantitative Analysis of Changes in Anterior Chamber After Laser Peripheral Lridotomy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
January 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Second Xiangya Hospital of Central South University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Angle Closure Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
laser peripheral iridotomy
Arm Type
Other
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Laserex Tango Nd:YAG, Ellex-SuperQ Medical, Australia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in anterior chamber after LPI at 1 month
Time Frame
1month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haomin Luo, Ph.D student
Phone
+86 13875830738
Email
lhmqqpp@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xuanchu Duan, Ph.D
Organizational Affiliation
Central South University
Official's Role
Study Director
Facility Information:
Facility Name
The Second Xiangya Hospital of Central South University,
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haomin Luo, Ph.D student
Phone
+86 13875830738
Email
lhmqqpp@163.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
17452177
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. doi: 10.1016/j.ajo.2006.11.055. Epub 2006 Dec 29.
Results Reference
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PubMed Identifier
23599331
Citation
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.
Results Reference
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Optical Coherence Tomography Quantitative Analysis of Changes in Anterior Chamber After Laser Peripheral Lridotomy

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