- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04666870
Axis Length and Its Relationship With Refractive Error in Chinese University Students
December 8, 2020 updated by: Wang Hongxia
Shanghai Guanghua Integrated Traditional Chinese and Western Medicine Hospital, Guanghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
1901
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
-
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Shanghai
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Shanghai, Shanghai, China, 200052
- Shanghai Guanghua Integrated Traditional Chinese and Western Medicine Hospital
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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
22 years to 26 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
The subject recruited for the study were 1935 students
Description
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
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 |
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.
|
visual acuity, IOL master biometry, the anterior segment with slit lamp, dilated fundus examination and refraction.
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gender
male were 54.29% (N=1032), and female were 45.71% (N=869)
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visual acuity, IOL master biometry, the anterior segment with slit lamp, dilated fundus examination and refraction.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Axis length
Time Frame: from baseline at 6 months
|
Axis length change from baseline at 6 months
|
from baseline at 6 months
|
Refractive Error
Time Frame: from baseline at 6 months
|
Refractive Error change from baseline at 6 months
|
from baseline at 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Hongxia Wang, director, Shanghai Guanghua Integrated Traditional Chinese and Western Medicine 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
- Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123(5):1036-42. doi: 10.1016/j.ophtha.2016.01.006. Epub 2016 Feb 11.
- Kempen JH, Mitchell P, Lee KE, Tielsch JM, Broman AT, Taylor HR, Ikram MK, Congdon NG, O'Colmain BJ; Eye Diseases Prevalence Research Group. The prevalence of refractive errors among adults in the United States, Western Europe, and Australia. Arch Ophthalmol. 2004 Apr;122(4):495-505. doi: 10.1001/archopht.122.4.495. Erratum In: Arch Ophthalmol. 2005 Oct;123(10):1314.
- Morgan IG, Ohno-Matsui K, Saw SM. Myopia. Lancet. 2012 May 5;379(9827):1739-48. doi: 10.1016/S0140-6736(12)60272-4.
- Mountjoy E, Davies NM, Plotnikov D, Smith GD, Rodriguez S, Williams CE, Guggenheim JA, Atan D. Education and myopia: assessing the direction of causality by mendelian randomisation. BMJ. 2018 Jun 6;361:k2022. doi: 10.1136/bmj.k2022. Erratum In: BMJ. 2018 Jul 4;362:k2932.
- Dolgin E. The myopia boom. Nature. 2015 Mar 19;519(7543):276-8. doi: 10.1038/519276a. No abstract available.
- Spillmann L. Stopping the rise of myopia in Asia. Graefes Arch Clin Exp Ophthalmol. 2020 May;258(5):943-959. doi: 10.1007/s00417-019-04555-0. Epub 2019 Dec 23.
- Battersby K, Koy L, Phillips N, Sim J, Wilk J, Schmid KL. Analysis of physical activity in emmetropic and myopic university students during semester and holiday periods: a pilot study. Clin Exp Optom. 2015 Nov;98(6):547-54. doi: 10.1111/cxo.12327.
- Tideman JWL, Polling JR, Jaddoe VWV, Vingerling JR, Klaver CCW. Growth in foetal life, infancy, and early childhood and the association with ocular biometry. Ophthalmic Physiol Opt. 2019 Jul;39(4):245-252. doi: 10.1111/opo.12630.
- Jonas JB, Ohno-Matsui K, Panda-Jonas S. Myopia: Anatomic Changes and Consequences for Its Etiology. Asia Pac J Ophthalmol (Phila). 2019 Sep-Oct;8(5):355-359. doi: 10.1097/01.APO.0000578944.25956.8b.
- Ohno-Matsui K, Lai TY, Lai CC, Cheung CM. Updates of pathologic myopia. Prog Retin Eye Res. 2016 May;52:156-87. doi: 10.1016/j.preteyeres.2015.12.001. Epub 2016 Jan 6.
- Paluru P, Ronan SM, Heon E, Devoto M, Wildenberg SC, Scavello G, Holleschau A, Makitie O, Cole WG, King RA, Young TL. New locus for autosomal dominant high myopia maps to the long arm of chromosome 17. Invest Ophthalmol Vis Sci. 2003 May;44(5):1830-6. doi: 10.1167/iovs.02-0697.
- Wang J, Ying GS, Fu X, Zhang R, Meng J, Gu F, Li J. Prevalence of myopia and vision impairment in school students in Eastern China. BMC Ophthalmol. 2020 Jan 2;20(1):2. doi: 10.1186/s12886-019-1281-0.
- Richter GM, Wang M, Jiang X, Wu S, Wang D, Torres M, Choudhury F, Varma R; Chinese American Eye Study Group. Ocular Determinants of Refractive Error and Its Age- and Sex-Related Variations in the Chinese American Eye Study. JAMA Ophthalmol. 2017 Jul 1;135(7):724-732. doi: 10.1001/jamaophthalmol.2017.1176.
- Rozema JJ, Sun W, Wu JF, Jiang WJ, Wu H, Lu TL, Hu YY, Chen R, Guo DD, Wang XR, Dankert S, Jonas JB, Iribarren R, Tian QM, Bi HS. Differences in ocular biometry between urban and rural children matched by refractive error: the Shandong Children Eye Study. Ophthalmic Physiol Opt. 2019 Nov;39(6):451-458. doi: 10.1111/opo.12649.
- Mallen EA, Gammoh Y, Al-Bdour M, Sayegh FN. Refractive error and ocular biometry in Jordanian adults. Ophthalmic Physiol Opt. 2005 Jul;25(4):302-9. doi: 10.1111/j.1475-1313.2005.00306.x.
- Zadnik K, Mutti DO, Mitchell GL, Jones LA, Burr D, Moeschberger ML. Normal eye growth in emmetropic schoolchildren. Optom Vis Sci. 2004 Nov;81(11):819-28. doi: 10.1097/01.opx.0000145028.53923.67.
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 21, 2019
Primary Completion (Actual)
July 30, 2019
Study Completion (Actual)
August 11, 2019
Study Registration Dates
First Submitted
November 2, 2020
First Submitted That Met QC Criteria
December 8, 2020
First Posted (Actual)
December 14, 2020
Study Record Updates
Last Update Posted (Actual)
December 14, 2020
Last Update Submitted That Met QC Criteria
December 8, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-K-106
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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