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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03159780
Other study ID # ZhongshanOC20170503
Secondary ID
Status Completed
Phase N/A
First received May 17, 2017
Last updated October 30, 2017
Start date January 1, 2017
Est. completion date August 31, 2017

Study information

Verified date October 2017
Source Zhongshan Ophthalmic Center, Sun Yet-sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 808
Est. completion date August 31, 2017
Est. primary completion date August 31, 2017
Accepts healthy volunteers No
Gender All
Age group 40 Years to 100 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Zhongshan Ophthalmic Center Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Mingkai Lin

Country where clinical trial is conducted

China, 

References & Publications (3)

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 contro — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Prevalence of keratometry 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)
Secondary Prevalence of axial length 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)
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