Prevalence of Corneal Astigmatism Before Glaucoma Surgery in Chinese Patients With Primary Angle-closure Glaucoma

October 30, 2017 updated by: Mingkai Lin
Clear-lens extraction has been considered as first-line therapy for primary angle closure glaucoma(PACG) and application of toric intraocular lens (IOLs) leads to better postoperative visual acuity, yet little is known about the prevalence of corneal astigmatism in PACG patients. We intend to make biometry examination for Chinese PACG patients, to obtain keratometry (K) , axial length (AL) and so on, and demographics data will also be recorded. We will study the prevalence of corneal astigmatism before glaucoma surgery in Chinese patients with PACG. Furthermore, differences of corneal astigmatism between primary angle-closure glaucoma and cataract patients will be explored. Finally, the prevalence of corneal astigmatism before glaucoma surgery in Chinese patients with PACG will be portrayed and can be instructive to the IOLs' manufactering.

Study Overview

Status

Completed

Detailed Description

Biometry examination contains keratometry (K) , axial length (AL), central anterior chamber depth, visual field loss(mean deviation, MD), choroidal thickness(CT), range of goniosynechia, and stage of PACG.

Demographics data contains age, gender, and eye.

Study Type

Observational

Enrollment (Actual)

808

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Zhongshan Ophthalmic Center

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

Ages Eligible for Study

40 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary angle closure was defi ned as iridotrabecular contact, either appositional or synechial, of at least 180° on gonioscopy, and primary angle-closure glaucoma as reproducible glaucomatous visual fi eld defects, glaucomatous optic neuropathy, or both, and intraocular pressure greater than 21 mm Hg on at least one occasion.

Description

Inclusion Criteria:

  • Patients who are phakic and aged 40 years or older , and had newly diagnosed primary angle closure with intraocular pressure 30 mm Hg or greater or primary angle-closure glaucoma, will be recruited during preoperative screening at Zhongshan Ophthalmic Center.

Exclusion Criteria:

  • Patients with corneal disease, irregular astigmatism, previous corneal or intraocular surgery, or a history of ocular inflammation will be excluded.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of corneal astigmatism
Time Frame: During preoperative screening (1 day)
Data of corneal astigmatism will be acquired through examination,and different types of corneal astigmatism will be diagnosed and seperated.Moreover,we will analyse the prevalence of corneal astigmatism,and compare among different age groups and different genders.Correlation between demographic features and data will be analysed,too.
During preoperative screening (1 day)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of keratometry
Time Frame: During preoperative screening (1 day)
Flat,steep and mean keratometry will be examined before glaucoma surgery. Moreover,we will analyse the prevalence of corneal astigmatism,and compare among different age groups and different genders.
During preoperative screening (1 day)
Prevalence of axial length
Time Frame: During preoperative screening (1 day)
Axial length will be measured by both IOL Master and A-scan, and data will be compared between different measurements,different genders and different age groups.
During preoperative screening (1 day)

Collaborators and Investigators

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

Sponsor

Investigators

  • Principal Investigator: Mingkai Lin, MD, Zhongshan Ophthalmic Center, Sun Yat-sen University

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.

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)

January 1, 2017

Primary Completion (Actual)

August 31, 2017

Study Completion (Actual)

August 31, 2017

Study Registration Dates

First Submitted

May 17, 2017

First Submitted That Met QC Criteria

May 18, 2017

First Posted (Actual)

May 19, 2017

Study Record Updates

Last Update Posted (Actual)

October 31, 2017

Last Update Submitted That Met QC Criteria

October 30, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • ZhongshanOC20170503

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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