NCT03159780

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
808

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 19, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
Last Updated

October 31, 2017

Status Verified

October 1, 2017

Enrollment Period

8 months

First QC Date

May 17, 2017

Last Update Submit

October 30, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of corneal astigmatism

    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 Outcomes (2)

  • Prevalence of keratometry

    During preoperative screening (1 day)

  • Prevalence of axial length

    During preoperative screening (1 day)

Eligibility Criteria

Age40 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (4)

  • Azuara-Blanco A, Burr J, Ramsay C, Cooper D, Foster PJ, Friedman DS, Scotland G, Javanbakht M, Cochrane C, Norrie J; EAGLE study group. Effectiveness of early lens extraction for the treatment of primary angle-closure glaucoma (EAGLE): a randomised controlled trial. Lancet. 2016 Oct 1;388(10052):1389-1397. doi: 10.1016/S0140-6736(16)30956-4.

  • Gao X, Huang W, Wang W, Zhou M, Wang J, Du S, Chen S, Zhang X. Topographic profile of choroid in eyes after acute primary angle-closure. Can J Ophthalmol. 2016 Oct;51(5):354-361. doi: 10.1016/j.jcjo.2016.02.025. Epub 2016 Sep 3.

  • Chen W, Zuo C, Chen C, Su J, Luo L, Congdon N, Liu Y. Prevalence of corneal astigmatism before cataract surgery in Chinese patients. J Cataract Refract Surg. 2013 Feb;39(2):188-92. doi: 10.1016/j.jcrs.2012.08.060. Epub 2012 Nov 7.

  • Zuo C, Gong R, Chen W, Chen C, Su J, Wei K, Gao X, Lin M, Ge J. Investigation of Corneal Astigmatism in Chinese Patients With Primary Angle Closure Disease. J Glaucoma. 2018 Dec;27(12):1131-1135. doi: 10.1097/IJG.0000000000001061.

MeSH Terms

Conditions

Glaucoma, Angle-ClosureAstigmatism

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye DiseasesRefractive Errors

Study Officials

  • Mingkai Lin, MD

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Glaucoma Center

Study Record Dates

First Submitted

May 17, 2017

First Posted

May 19, 2017

Study Start

January 1, 2017

Primary Completion

August 31, 2017

Study Completion

August 31, 2017

Last Updated

October 31, 2017

Record last verified: 2017-10

Locations