Biometry of Occult Lens Subluxation Misdiagnosed as Primary Acute Angle Closed Glaucoma

November 25, 2018 updated by: Lv Yingjuan, Tianjin Medical University Eye Hospital

Biometric Indicators of Eyes With Occult Lens Subluxation

In this work, we evaluated the biometry data of lens subluxation inducing acute angle closure which were misdiagnosed as primary angle closure at the first visit, and compared with the data of chronic angle closure glaucoma, cataract, primary acute angle closure.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
183

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This retrospective case study included 17 eyes of 17 patients with ASAC-LS, who were misdiagnosed with APACG on their first visit. In addition, 56 eyes of 56 patients diagnosed with APACG, 54 eyes of 54 patients diagnosed with CPACG, and 56 eyes of 56 patients diagnosed with cataract were also included. All of the patients were admitted from Jan 10, 2016 to Dec 28, 2017 in Tianjin Medical University Hospital. This study was conducted in accordance with the Helsinki Declaration and was approved by the Ethics Committee of Tianjin Medical University Eye Hospital.

Description

ASAC-LS was diagnosed according to the following criteria, including sudden pain in the eye, decreased vision with or without nausea and vomiting. Slit lamp microscopy reveals phacodonesis, lens inclination or vitreous herniation into the anterior chamber, central and peripheral shallow anterior chamber, and asymmetric iris bulge. All patients were confirmed during the surgery to have LS.

APACG was diagnosed with the following criteria6, 7 8, including substantially elevated IOP and closed angle, acute eye pain, blurred vision, or nausea and vomiting. More importantly, ischemic injury caused by acute ocular hypertension, ciliary or mixed congestion, corneal edema, and glaucoma flecks should be detected.

The diagnostic criteria of CPACG included narrow angle with anterior synechiae of varying widths, IOP > 22 mmHg, and glaucomatous optic disc damage and visual field shrinkage9-11 The angle closure should be more than two quadrants, yet there was no ischemic injury in the anterior segment caused by acute ocular hypertension.

Exclusion criteria were history of laser peripheral iridotomy or peripheral iridectomy, glaucoma filtration surgery, angle closure caused by ocular trauma, uveitis, neovascularization or lens swelling or hyper mature lens. The patients with acute angle closure in both eyes were excluded. The subjects in which Lenstar LS900 examination could not be performed because of severe lens opacity or corneal edema were also not included in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Acute primary angle closure
Acute secondary angle closure induced by LS
Cataract
Primary chronic angle closed glaucoma

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Eye anterior segment biometry
Time Frame: 1 day
Anterior segment biometry measure by Lenstar LS900
1 day
Intraocular pressure
Time Frame: 1 year
Intraocular pressure was measured by Goldmann tonometer
1 year
visual acuity
Time Frame: 1 year
visual acuity before and after surgery
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tianjin Medical University Eye Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 27, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Tianjin LS study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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