Assess the Effects of Spectacles or Orthokeratology on Dry Eye Parameters in Children and Adolescents.

September 10, 2023 updated by: He Eye Hospital

A Single Center,Randomized,Controlled Trial Assessing the Effects of Spectacles or Orthokeratology on Dry Eye Parameters in Children and Adolescents.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will be conducted in compliance with the tenets of the Declaration of Helsinki and the Institutional Review Board of He Eye Specialist Hospital, Shenyang, China [ethics approval number:

In recent years, the prevalence of myopia has significantly increased nationwide, The incidence rate of myopia among adolescents in China has risen significantly, causing blurred vision. Severe myopia can cause complications that threaten vision, such as glaucoma and macula disease. It would be highly undesirable to increase the social burden. Myopia can be corrected by orthokeratology (OK) and spectacles. It has been shown in numerous researches that orthokeratology lens are recognized as one of the effective methods in the treatment of myopia, has been widely used nationwide. In current years, the clinical treatment of myopia by OK lens in adolescents are increasingly confirmed to prevent the progression. Traditional OK lenses change refractive power by reshaping the corneal Epithelium (leading to the redistribution of corneal epithelium). As the overnight OK lens directly contact the ocular surface, the patients may endure symptoms and signs of dry eye disease (DED), which may even have some impact on the health of the ocular surface, including potential complications such as Keratitis. In addition, corneal staining often has occurred in ook wearers. According to previous studies, it has shown that wearing contact lens will affect the tear film stability, damage the function of the meibomian gland, tear film thinning, its affect ocular inflammation. Recent studies have also shown that OK continuous wearing has the least impact at 12 months. In order to ensure the safety of long-term wearing ok lenses in children and adolescents, the effect of OK lens on tear film and meibomian gland demonstrated further exploration.

The aim of this study is to evaluate the effect of OK on the ocular surface and meibomian gland function in children and adolescents. To assess the effect of OK on ocular surface and meibomian gland function in children and adolescents, so as to improve the application of the clinical.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • He Eye Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Jiyan Chen, MSc

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

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

(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.

Exclusion Criteria:

(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.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Orthokeratology group
Participants in OK lenses group will wear OK lenses at least 8 hours per day for 12 months.
Device: Orthokeratology
OK lenses will be used to evaluate the condition that causes dry eye in the treatment of myopia.
Other Names:
  • OK lenses
Active Comparator: Spectacles group
Participants in spectacles group will wear per day for 12 months.
Device: Spectacles
Spectacles will be used to evaluate the condition that causes dry eye in the treatment of myopia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-invasive tear break-up time
Time Frame: Day-0 (baseline), 1-month ,3-month,6-month and 12-month.
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
Time Frame: Day-0 (baseline), 1-month ,3-month,6-month and 12-month.
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
Time Frame: Day-0 (baseline), 1-month ,3-month,6-month and 12-month.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tear meniscus height (TMH)
Time Frame: Day-0 (baseline), 1-month ,3-month,6-month and 12-month.
Tear meniscus height using the Keratograph 5M (Oculus, Germany) topographer
Day-0 (baseline), 1-month ,3-month,6-month and 12-month.
Conjunctival hyperemia (RS score)
Time Frame: Day-0 (baseline), 1-month ,3-month,6-month and 12-month.
Conjunctival hyperemia (RS score) will be assessed by keratograph image (Oculus, Germany) of 1156*873 pixels, redness score (RS) (accurate to 0.1 U) was displayed on the computer screen that ranged from 0.0 to 4.0.
Day-0 (baseline), 1-month ,3-month,6-month and 12-month.
Meibomian gland score (meiboscore)
Time Frame: Day-0 (baseline), 1-month ,3-month,6-month and 12-month.
Meibomian gland score will be assessed by keratograph image (Oculus, Germany) .The meibomian gland can be scored that ranges from grade 0 (no loss) to grade 3 (more than two third loss).
Day-0 (baseline), 1-month ,3-month,6-month and 12-month.
MMP-9 detection
Time Frame: Day-0 (baseline), 1-month ,3-month,6-month and 12-month.
Inflammation Dry, (Rapid Pathogen Screening Inc., Sarasota, FL, USA) is a patented and proprietary modification of a traditional lateral flow device and uses direct sampling microfiltration technology.
Day-0 (baseline), 1-month ,3-month,6-month and 12-month.
LTA
Time Frame: Day-0 (baseline), 1-month ,3-month,6-month and 12-month.
LTA will be measured using an immunochromatography assay by collecting 1ul tear samples from the lateral canthus using a capillary tear collector. To assess the concentration of LTA in the tear samples, a commercial reagent card (S05B, Seinda Biomedical Corporation, Guangdong, China) based on colloidal gold and immunochromatographic analysis was utilized.
Day-0 (baseline), 1-month ,3-month,6-month and 12-month.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

He Eye Hospital

Investigators

  • Study Chair: Emmanuel Eric E Pazo, PHD, He Eye Hospital, Shenyang, China

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

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 (Estimated)

November 23, 2023

Primary Completion (Estimated)

November 30, 2023

Study Completion (Estimated)

January 30, 2024

Study Registration Dates

First Submitted

August 29, 2023

First Submitted That Met QC Criteria

August 29, 2023

First Posted (Actual)

September 5, 2023

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 10, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • orthokeratology 2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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