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Refractive Error - Myopia AxialNCT04666870

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

An observational study of Refractive Error - Myopia Axial, run by Wang Hongxia at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 22 to 26 years
Conditions the study is for
Refractive Error - Myopia Axial
What is being tested?
myopia or not myopia
How many people
1,901 participants
Where
1 siteChina
Study dates
21 Jan 2019to 11 Aug 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 26 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: The subject recruited for the study were 1935 students

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Guanghua Integrated Traditional Chinese and Western Medicine Hospital

    Shanghai, Shanghai Municipality, 200052

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
myopia or not myopia
Keywords
China, high myopia, hyperopia, emmetropia
Medical subject headings
Hyperopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • myopia or not myopiaOther

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

Study groups in NCT04666870
Study groupRoleWhat they receive
axis length1007 healthy students with moderate to high myopia (SE ≤ -4.00D) and 894 without myopia (-0.50D ≤ spherical power ≤ +2.00D) were enrolled.
Receives: Other: myopia or not myopia
gendermale were 54.29% (N=1032), and female were 45.71% (N=869)
Receives: Other: myopia or not myopia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Axis length

    Axis length change from baseline at 6 months

    Measured: from baseline at 6 months

  2. Refractive Error

    Refractive Error change from baseline at 6 months

    Measured: from baseline at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2020
  2. Study start21 Jan 2019
  3. Primary completion30 Jul 2019
  4. Study completion11 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
1,901 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04666870
Sponsor's protocol ID
2020-K-106
Status last verified
Dec 2020
First submitted
2 Nov 2020
Last updated
14 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 26875007

  • 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.

    PubMed 15078666

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

    PubMed 22559900

  • 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.

    PubMed 29875094

  • Dolgin E. The myopia boom. Nature. 2015 Mar 19;519(7543):276-8. doi: 10.1038/519276a. No abstract available.

    PubMed 25788077

  • 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.

    PubMed 31873785

  • 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.

    PubMed 26769178

  • 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.

    PubMed 31236981

  • 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.

    PubMed 31425168

  • 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.

    PubMed 26769165

  • 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.

    PubMed 12714612

  • 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.

    PubMed 31898504

  • 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.

    PubMed 28520882

  • 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.

    PubMed 31696541

  • 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.

    PubMed 15953114

Questions about this trial

What is this clinical trial studying?

An observational study of Refractive Error - Myopia Axial, run by Wang Hongxia at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Axis length (time frame: from baseline at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04666870, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2020.

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