Predicting the Effect of Laser Peripheral Iridotomy

NCT ID: NCT04495491

Last Updated: 2020-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2021-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Primary angle-closure glaucoma is the leading cause of blindness worldwide. It is associated with increased intraocular pressure, which causes optic nerve damage and field defects if untreated. The aqueous humor leaves the anterior chamber through the trabecular meshwork and flows into the aqueous vein and the superior scleral vein through the collector channels and Schlemm's canal. If the trabecular meshwork is not blocked, a wide angle allows enough aqueous humor to drain out. The iris corneal translocation may lead to angle-closure glaucoma.

Laser peripheral iridectomy is recognized as the best surgical method to relieve pupil block. Previous studies have shown increased anterior chamber depth (ACD), area (ACA), and volume (ACV), and increased Angle open distance (AOD) after LPI surgery.

However, postoperative outcomes of LPI were not the same for patients with different angle closure mechanisms.

Postoperative outcomes for LPI were best for patients with pupillary block type, but were moderate for patients with plateau iris group and mixed group.

The purpose of this study, conducted in Chinese subjects, aims to use UBM to evaluate changes in the anterior segment parameters of LPI, and to propose methods to predict postoperative outcomes of LPI.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glaucoma

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

laser peripheral iridotomy primary angle closure suspect angle closure mechanism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pupillary block group

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

pupillary block group

Intervention Type OTHER

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

plateau iris group

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

plateau iris group

Intervention Type OTHER

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

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.

mixing mechanism group

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

pupillary block group

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

Intervention Type OTHER

plateau iris group

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

Intervention Type OTHER

mixing 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

1. severe health problems resulting in a life expectancy of less than 1 year;
2. previous intraocular surgery or penetrating eye injury;
3. media opacity preventing laser peripheral iridotomy;
4. Researchers think not suitable to participate in this clinical trial subjects;
5. Refused to sign the informed consent.;
6. 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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mingkai Lin

chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mingkai Lin, MD

Role: STUDY_CHAIR

Zhongshan Ophthalmic Center, Sun Yat-San University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Zhongshan Ophthalmic Center, Sun Yat-San Univerdity

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yuying Zhou, Master

Role: CONTACT

Phone: 8615270988097

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yuying Zhou, Master

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 30878226 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17123610 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16799014 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019KYPJ182

Identifier Type: -

Identifier Source: org_study_id