NCT02279472

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 31, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

October 31, 2014

Status Verified

October 1, 2014

Enrollment Period

2 months

First QC Date

September 30, 2014

Last Update Submit

October 28, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in anterior chamber after LPI at 1 month

    1month

Study Arms (1)

laser peripheral iridotomy

OTHER

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

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

Interventions

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.

laser peripheral iridotomy

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Xiangya Hospital of Central South University,

Changsha, Hunan, 410000, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 17452177BACKGROUND
  • 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.

    PMID: 23599331BACKGROUND

MeSH Terms

Conditions

Glaucoma, Angle-Closure

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Officials

  • Xuanchu Duan, Ph.D

    Second Xiangya Hospital of Central South University

    STUDY DIRECTOR

Central Study Contacts

Haomin Luo, Ph.D student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Haomin Luo M.d.

Study Record Dates

First Submitted

September 30, 2014

First Posted

October 31, 2014

Study Start

October 1, 2014

Primary Completion

December 1, 2014

Study Completion

January 1, 2015

Last Updated

October 31, 2014

Record last verified: 2014-10

Locations