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

Refractive Error - Myopia Axial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04666870
• Other study ID #: 2020-K-106
• Status: Completed
• Start date: January 21, 2019
• Est. completion date: August 11, 2019

Study information

• Verified date: December 2020
• Source: Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1901
• Est. completion date: August 11, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 26 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia
• Refractive Error - Myopia Axial
• Refractive Errors

Intervention

Other:
• myopia or not myopia
visual acuity, IOL master biometry, the anterior segment with slit lamp, dilated fundus examination and refraction.

Locations

Country	Name	City	State
China	Shanghai Guanghua Integrated Traditional Chinese and Western Medicine Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Wang Hongxia	Tianjin Eye Hospital

Country where clinical trial is conducted

China, 

References & Publications (16)

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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 Ophthal — View Citation

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. — View Citation

Morgan IG, Ohno-Matsui K, Saw SM. Myopia. Lancet. 2012 May 5;379(9827):1739-48. doi: 10.1016/S0140-6736(12)60272-4. Review. — View Citation

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 — View Citation

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. Review. — View Citation

Paluru P, Ronan SM, Heon E, Devoto M, Wildenberg SC, Scavello G, Holleschau A, Mäkitie 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. — View Citation

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 — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Axis length	Axis length change from baseline at 6 months	from baseline at 6 months
Primary	Refractive Error	Refractive Error change from baseline at 6 months	from baseline at 6 months