Axis Length and Its Relationship With Refractive Error in Chinese University Students

Sponsor

Wang Hongxia (Other)

Overall Status

Completed

CT.gov ID

NCT04666870

Collaborator

Tianjin Eye Hospital (Other)

1,901

Enrollment

Location

6.6

Actual Duration (Months)

286.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To investigate the relationship between axis length (AL) and refractive error. eyes of low hyperopia to emmetropia subjects, comprising eyes with moderate to high myopia (-11.00D ≤ SE ≤ -4.00D) were analyzed in this cross-sectional study. Cycloplegic refractive error was measured with the autorefractor, AL was measured with the IOL master. Association between AL and refractive error were evaluated by linear regression analysis. The mean of AL and its correlation with SE, sex, and age were evaluated.

Condition or Disease	Intervention/Treatment	Phase
Refractive Error - Myopia Axial	Other: myopia or not myopia

Detailed Description

To investigate the relationship between axis length (AL) and refractive error (RE). 894 eyes with low hyperopia to emmetropia (-0.50D ≤ spherical equivalent (SE) ≤ +2.00D), comprising 1007 eyes with moderate to high myopia (-11.00D ≤ SE ≤ -4.00D) were analyzed in this study. Cycloplegic RE was measured with the autorefractor, AL was measured with the IOL master. Association between AL and refractive error were evaluated by linear regression analysis. The mean of AL and its correlation with SE, sex, and age were evaluated.

Study Design

Study Type:

Observational

Actual Enrollment :

1901 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

Shanghai Guanghua Integrated Traditional Chinese and Western Medicine Hospital, Guanghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China

Actual Study Start Date :

Jan 21, 2019

Actual Primary Completion Date :

Jul 30, 2019

Actual Study Completion Date :

Aug 11, 2019

Arms and Interventions

Arm	Intervention/Treatment
axis length 1007 healthy students with moderate to high myopia (SE ≤ -4.00D) and 894 without myopia (-0.50D ≤ spherical power ≤ +2.00D) were enrolled.	Other: myopia or not myopia visual acuity, IOL master biometry, the anterior segment with slit lamp, dilated fundus examination and refraction.
gender male were 54.29% (N=1032), and female were 45.71% (N=869)	Other: myopia or not myopia visual acuity, IOL master biometry, the anterior segment with slit lamp, dilated fundus examination and refraction.

Arm

Intervention/Treatment

axis length

1007 healthy students with moderate to high myopia (SE ≤ -4.00D) and 894 without myopia (-0.50D ≤ spherical power ≤ +2.00D) were enrolled.

Other: myopia or not myopia

visual acuity, IOL master biometry, the anterior segment with slit lamp, dilated fundus examination and refraction.

gender

male were 54.29% (N=1032), and female were 45.71% (N=869)

Other: myopia or not myopia

visual acuity, IOL master biometry, the anterior segment with slit lamp, dilated fundus examination and refraction.

Outcome Measures

Primary Outcome Measures

Axis length [from baseline at 6 months]
Axis length change from baseline at 6 months
Refractive Error [from baseline at 6 months]
Refractive Error change from baseline at 6 months

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years to 26 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

with moderate to high myopia (SE ≤ -4.00D) without myopia (-0.50D ≤ spherical power ≤ +2.00D) no concurrent eye disease best corrected visual acuity is 1.0

Exclusion Criteria:

significant systemic illnesses congenital myopia, media opacity uveitis glaucoma intraocular surgery refractive surgery neurologic diseases retinal disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Guanghua Integrated Traditional Chinese and Western Medicine Hospital	Shanghai	Shanghai	China	200052

Sponsors and Collaborators

Wang Hongxia
Tianjin Eye Hospital

Investigators

Study Director: Hongxia Wang, director, Shanghai Guanghua integrated traditional Chinese and Western Medicine Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wang Hongxia, Shanghai Guanghua Integrated Traditional Chinese and Western Medicine Hospital, Guanghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

ClinicalTrials.gov Identifier:

NCT04666870

Other Study ID Numbers:

2020-K-106

First Posted:

Dec 14, 2020

Last Update Posted:

Dec 14, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Wang Hongxia, Shanghai Guanghua Integrated Traditional Chinese and Western Medicine Hospital, Guanghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

Additional relevant MeSH terms:

Myopia

Refractive Errors

Study Results

No Results Posted as of Dec 14, 2020