Predicting the Effect of Laser Peripheral Iridotomy

NCT04495491 | Unknown

• 1 other identifier: 2019KYPJ182
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the angle parameters of patients with PACS before and after LPI. The investigators will analyze the results of patients with different angle closure mechanisms before and after LPI, and participants hope to find the structural parameters for predicting the effect of LPI.

Conditions

Glaucoma

Keywords

laser peripheral iridotomy; primary angle closure suspect; angle closure mechanism

Outcome Measures

Primary Outcomes (1)

• the changes in anterior opening distance before and after LPI

  To compare the difference of anterior opening distance after LPI and baseline parameters before LPI. Anterior opening distance, measured on a line perpendicular to the plane of the trabecular surface 500 μm anterior to the scleral spur and extended to meet the surface of the iris

  between the baseline and 1 hour before discharge

Study Arms (3)

Pupillary block group

According to the configurations of angle closure, the pupillary block group is defined as the iris bombe.

Other: pupillary block group

plateau iris group

According to the configurations of angle closure, the plateau iris group is defined as the thickness of the peripheral iris.

Other: plateau iris group

mixed mechanism group

According to the configurations of angle closure, the mixing mechanism group is defined as the iris bombe plus thickening of the peripheral iris.

Other: mixing mechanism group

Interventions

pupillary block group OTHER

According to the configurations of angle closure, the pupillary block group is defined as the iris bombe.

Pupillary block group

plateau iris group OTHER

According to the configurations of angle closure, the plateau iris group is defined as the thickness of the peripheral iris.

plateau iris group

mixing mechanism group OTHER

According to the configurations of angle closure, the mixing mechanism group is defined as the iris bombe plus thickening of the peripheral iris.

mixed mechanism group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chinese Patient was diagnosed of primary angle closure angle suspect

You may qualify if:

• Patient was diagnosed of primary angle closure angle suspect;
• received ultrasound Biomicroscopy before and after laser peripheral iridotomy;
• Voluntary participation in this study;
• Have enough language comprehension ability;
• Patient or his legal representative has sign the informed consent.

You may not qualify if:

• severe health problems resulting in a life expectancy of less than 1 year;
• previous intraocular surgery or penetrating eye injury;
• media opacity preventing laser peripheral iridotomy;
• Researchers think not suitable to participate in this clinical trial subjects;
• Refused to sign the informed consent.;
• There are important viscera function failure or other serious disease, including clinical related coronary artery disease, cardiovascular disease or myocardial infarction into the group of the first six months; serious neurological or psychiatric illness; serious infections; coagulant function abnormality; general active infectious diseases; malignant tumor; serious immune diseases.

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-San Univerdity

Guangzhou, Guangdong, China

RECRUITING

Related Publications (3)

• He M, Jiang Y, Huang S, Chang DS, Munoz B, Aung T, Foster PJ, Friedman DS. Laser peripheral iridotomy for the prevention of angle closure: a single-centre, randomised controlled trial. Lancet. 2019 Apr 20;393(10181):1609-1618. doi: 10.1016/S0140-6736(18)32607-2. Epub 2019 Mar 14.

  PMID: 30878226 BACKGROUND

• He M, Friedman DS, Ge J, Huang W, Jin C, Lee PS, Khaw PT, Foster PJ. Laser peripheral iridotomy in primary angle-closure suspects: biometric and gonioscopic outcomes: the Liwan Eye Study. Ophthalmology. 2007 Mar;114(3):494-500. doi: 10.1016/j.ophtha.2006.06.053. Epub 2006 Nov 21.

  PMID: 17123610 BACKGROUND

• He M, Foster PJ, Ge J, Huang W, Zheng Y, Friedman DS, Lee PS, Khaw PT. Prevalence and clinical characteristics of glaucoma in adult Chinese: a population-based study in Liwan District, Guangzhou. Invest Ophthalmol Vis Sci. 2006 Jul;47(7):2782-8. doi: 10.1167/iovs.06-0051.

  PMID: 16799014 BACKGROUND

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Mingkai Lin, MD

  Zhongshan Ophthalmic Center, Sun Yat-San University

  STUDY CHAIR

Central Study Contacts

Yuying Zhou, Master

CONTACT

8615270988097; 2053552500@qq.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 31, 2020
• Study Start: July 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: March 31, 2021
• Last Updated: July 31, 2020

Record last verified: 2020-07

Locations

CN (1)