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

Sponsor

He Eye Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06023108

Collaborator

(none)

300

Enrollment

Location

Arms

5.3

Anticipated Duration (Months)

57.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Disease	Device: Orthokeratology Device: Spectacles	N/A

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 [1], The incidence rate of myopia among adolescents in China has risen significantly [2], [3], causing blurred vision. Severe myopia can cause complications that threaten vision, such as glaucoma and macula disease [4] 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 [5], [6], 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) [7]. 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 [2]. In addition, corneal staining often has occurred in ook wearers [8].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 [9]-[11]. Recent studies have also shown that OK continuous wearing has the least impact at 12 months [12]. In order to ensure the safety of long-term wearing ok lenses in children and adolescents, the effect of ook 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 Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 23, 2023

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Jan 30, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Non-invasive tear break-up time [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.
OSDI Score [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.
VAS score [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).

Secondary Outcome Measures

Tear meniscus height (TMH) [Day-0 (baseline), 1-month ,3-month,6-month and 12-month.]
Tear meniscus height using the Keratograph 5M (Oculus, Germany) topographer
Conjunctival hyperemia (RS score) [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.
Meibomian gland score (meiboscore) [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).
MMP-9 detection [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.
LTA [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.