NCT04666870

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,901

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

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 21, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 2, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 14, 2020

Completed
Last Updated

December 14, 2020

Status Verified

December 1, 2020

Enrollment Period

6 months

First QC Date

November 2, 2020

Last Update Submit

December 8, 2020

Conditions

Keywords

Chinahigh myopiahyperopiaemmetropia

Outcome Measures

Primary Outcomes (2)

  • Axis length

    Axis length change from baseline at 6 months

    from baseline at 6 months

  • Refractive Error

    Refractive Error change from baseline at 6 months

    from baseline at 6 months

Study Arms (2)

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

gender

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

Other: myopia or not myopia

Interventions

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

axis lengthgender

Eligibility Criteria

Age22 Years - 26 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The subject recruited for the study were 1935 students

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Guanghua Integrated Traditional Chinese and Western Medicine Hospital

Shanghai, Shanghai Municipality, 200052, China

Location

Related Publications (16)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Hyperopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Hongxia Wang, director

    Shanghai Guanghua integrated traditional Chinese and Western Medicine Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Shanghai Guanghua Integrated Traditional Chinese and Western Medicine Hospital, Guanghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Study Record Dates

First Submitted

November 2, 2020

First Posted

December 14, 2020

Study Start

January 21, 2019

Primary Completion

July 30, 2019

Study Completion

August 11, 2019

Last Updated

December 14, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations