NCT06023108

Brief Summary

Orthokeratology(OK) is currently one of the effective methods for treating myopia, reshaping the corneal epithelium to change refractive power. Due to its contact with the ocular surface, long-term wearing could lead to symptoms and signs of dry eye disease(DED) , as well as changes in tear film stability. This prospective study randomly divided 300 children and adolescents with myopia into OK group and spectacles group, with a follow-up of 12 months. At baseline, 1, 3, 6, and 12 months, non-invasive tear breakup time (NIBUT), ocular surface disease index (OSDI) and visual analogue score (VAS) score, tear meniscus height (TMH), conjunctival hyperemia (RS score) and meibomian gland (MG) scores, tear MMP-9 concentration, and point-of-care Lymphotoxin alpha (LTA) test.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 29, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 5, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

November 23, 2023

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

7 days

First QC Date

August 29, 2023

Last Update Submit

September 10, 2023

Conditions

Dry Eye Disease

Keywords

MyopiaOrthokeratologyTear filmDry eye

Outcome Measures

Primary Outcomes (3)

  • Non-invasive tear break-up time

    Non-invasive initial tear film breaking time will be assessed using the Keratograph 5M (Oculus, Germany) topographer. Three sequentially readings will be captured, and the median value will be included in the final analysis. The median value will be recorded.

    Day-0 (baseline), 1-month ,3-month,6-month and 12-month.

  • OSDI Score

    Chinese translated, and validated OSDI (Allergan Inc, Irvine, USA) version will be used to assess and quantify DE symptom. The 12 items of the questionnaire can be tabulated into a score that ranges from 0 (no symptoms) to 100 (severe symptoms) points.

    Day-0 (baseline), 1-month ,3-month,6-month and 12-month.

  • VAS score

    VAS is used to evaluate subjective symptoms, such as patient symptoms, emotions, etc. Composed of a 100 mm straight line, the end is defined as the limit of pain to be measured, resulting in a 100 component scale. The patient rated their eye discomfort by marking the continuity from 'no eye discomfort' (score 0) to 'my eye discomfort is as bad as ever' (score 100).

    Day-0 (baseline), 1-month ,3-month,6-month and 12-month.

Secondary Outcomes (5)

  • Tear meniscus height (TMH)

    Day-0 (baseline), 1-month ,3-month,6-month and 12-month.

  • Conjunctival hyperemia (RS score)

    Day-0 (baseline), 1-month ,3-month,6-month and 12-month.

  • Meibomian gland score (meiboscore)

    Day-0 (baseline), 1-month ,3-month,6-month and 12-month.

  • MMP-9 detection

    Day-0 (baseline), 1-month ,3-month,6-month and 12-month.

  • LTA

    Day-0 (baseline), 1-month ,3-month,6-month and 12-month.

Study Arms (2)

Orthokeratology group

EXPERIMENTAL

Participants in OK lenses group will wear OK lenses at least 8 hours per day for 12 months.

Device: Orthokeratology

Spectacles group

ACTIVE COMPARATOR

Participants in spectacles group will wear per day for 12 months.

Device: Spectacles

Interventions

OrthokeratologyDEVICE

OK lenses will be used to evaluate the condition that causes dry eye in the treatment of myopia.

Also known as: OK lenses
Orthokeratology group
SpectaclesDEVICE

Spectacles will be used to evaluate the condition that causes dry eye in the treatment of myopia.

Spectacles group

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • (i)myopia up to -5.5D; and with-the-rule astigmatism of up to 1.5 DC or against-the rule astigmatism of \<-0.5DC with keratometry from 40 to 45D ; (ii)participants and guardians agree to be randomly assigned and are willing to cooperate with doctors for follow-up and examination.

You may not qualify if:

  • (i) existing ocular trauma, infectious diseases, recent surgical history; (ii) keratitis or any ocular inflammation or infection; recently wearing contact lenses; allergy history; (iii) glaucoma, active uveitis or retinal disease; (iv) systemic diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

He Eye Hospital

Shenyang, Liaoning, 110001, China

Location

Related Publications (12)

  • Tao Z, Wang J, Zhu M, Lin Z, Zhao J, Tang Y, Deng H. Does Orthokeratology Wearing Affect the Tear Quality of Children? Front Pediatr. 2022 Jan 18;9:773484. doi: 10.3389/fped.2021.773484. eCollection 2021.

    PMID: 35118029RESULT

  • Hui W, Xiao-Feng H, Song-Guo L, Jing-Jing W, Xuan H, Yong T. Application of orthokeratology on myopia control and its effect on ocular surface and meibomian gland function in Chinese myopic adolescents. Front Med (Lausanne). 2022 Dec 8;9:979334. doi: 10.3389/fmed.2022.979334. eCollection 2022.

    PMID: 36569150RESULT

  • Yan ZP. Dry eye symptoms and signs in children wearing OK lenses for six months in China. J Fr Ophtalmol. 2020 Mar;43(3):211-215. doi: 10.1016/j.jfo.2019.07.029. Epub 2020 Jan 27.

    PMID: 32000988RESULT

  • Fricke TR, Holden BA, Wilson DA, Schlenther G, Naidoo KS, Resnikoff S, Frick KD. Global cost of correcting vision impairment from uncorrected refractive error. Bull World Health Organ. 2012 Oct 1;90(10):728-38. doi: 10.2471/BLT.12.104034. Epub 2012 Jul 12.

    PMID: 23109740RESULT

  • Kakita T, Hiraoka T, Oshika T. Influence of overnight orthokeratology on axial elongation in childhood myopia. Invest Ophthalmol Vis Sci. 2011 Apr 6;52(5):2170-4. doi: 10.1167/iovs.10-5485.

    PMID: 21212181RESULT

  • He M, Du Y, Liu Q, Ren C, Liu J, Wang Q, Li L, Yu J. Effects of orthokeratology on the progression of low to moderate myopia in Chinese children. BMC Ophthalmol. 2016 Jul 27;16:126. doi: 10.1186/s12886-016-0302-5.

    PMID: 27464993RESULT

  • Nti AN, Berntsen DA. Optical changes and visual performance with orthokeratology. Clin Exp Optom. 2020 Jan;103(1):44-54. doi: 10.1111/cxo.12947. Epub 2019 Aug 4.

    PMID: 31378996RESULT

  • Wang X, Li J, Zhang R, Li N, Pang Y, Zhang Y, Wei R. The Influence of Overnight Orthokeratology on Ocular Surface and Meibomian Gland Dysfunction in Teenagers with Myopia. J Ophthalmol. 2019 Jan 21;2019:5142628. doi: 10.1155/2019/5142628. eCollection 2019.

    PMID: 30805209RESULT

  • Yang L, Zhang L, Jian Hu R, Yu PP, Jin X. The influence of overnight orthokeratology on ocular surface and dry eye-related cytokines IL-17A, IL-6, and PGE2 in children. Cont Lens Anterior Eye. 2021 Feb;44(1):81-88. doi: 10.1016/j.clae.2020.04.001. Epub 2020 Apr 30.

    PMID: 32359968RESULT

  • Yu H, Yuan Y, Wu W, Zeng W, Tong L, Zhang Y, Feng Y. Orthokeratology Lens Wear for 2 Years in Children Did Not Alter Tear Film Lipid Thickness by Non-Invasive Interferometry. Front Med (Lausanne). 2022 Feb 10;9:821106. doi: 10.3389/fmed.2022.821106. eCollection 2022.

    PMID: 35223920RESULT

  • Lee J, Hwang G, Ha M, Kim HS, Han K, Na KS. Evaluation of the meibomian glands using the tear interferometer wearing orthokeratology lenses. BMC Ophthalmol. 2022 Mar 24;22(1):133. doi: 10.1186/s12886-022-02365-3.

    PMID: 35331178RESULT

  • Song Y, Chen J, Qin G, Xu L, He W, Yu S, Pazo EE, He X. A protocol for a single center, randomized, controlled trial assessing the effects of spectacles or orthokeratology on dry eye parameters in children and adolescents. Heliyon. 2024 Sep 12;10(18):e37779. doi: 10.1016/j.heliyon.2024.e37779. eCollection 2024 Sep 30.

    PMID: 39323780DERIVED

MeSH Terms

Conditions

Dry Eye SyndromesMyopia

Interventions

Eyeglasses

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye DiseasesRefractive Errors

Intervention Hierarchy (Ancestors)

LensesOptical DevicesEquipment and Supplies

Study Officials

  • Emmanuel Eric E Pazo, PHD

    He Eye Hospital, Shenyang, China

    STUDY CHAIR

Central Study Contacts

Emmanuel Eric E Pazo, PHD

CONTACT

0086-18612782131ericpazo@outlook.com

Yilin Song, MD

CONTACT

0086-18842649801songyilin1432@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2023

First Posted

September 5, 2023

Study Start

November 23, 2023

Primary Completion

November 30, 2023

Study Completion

January 30, 2024

Last Updated

September 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

The study's findings will be shared regardless of the effect's direction. All possible beneficiaries of the research, including patients, carers, family, doctors, advisory boards, and medical boards, will receive trial data. Publications in high-impact, open-access medical journals and talks at national and international medical conferences will serve this purpose.

Shared Documents
STUDY PROTOCOL

Locations

CN(1)