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

Dry Eye Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06023108
• Other study ID #: orthokeratology 2023
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 23, 2023
• Est. completion date: January 30, 2024

Study information

• Verified date: September 2023
• Source: He Eye Hospital
• Contact: Emmanuel Eric E Pazo, PHD
• Phone: 0086-18612782131
• Email: ericpazo[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: January 30, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Device:
• Orthokeratology
OK lenses will be used to evaluate the condition that causes dry eye in the treatment of myopia.
• Spectacles
Spectacles will be used to evaluate the condition that causes dry eye in the treatment of myopia.

Locations

Country	Name	City	State
China	He Eye Hospital	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
He Eye Hospital

Country where clinical trial is conducted

China, 

References & Publications (11)

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 — View Citation

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. — View Citation

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: 10.3 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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 20 — View Citation

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. eColl — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	Tear meniscus height (TMH)	Tear meniscus height using the Keratograph 5M (Oculus, Germany) topographer	Day-0 (baseline), 1-month ,3-month,6-month and 12-month.
Secondary	Conjunctival hyperemia (RS score)	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.
Secondary	Meibomian gland score (meiboscore)	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.
Secondary	MMP-9 detection	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.
Secondary	LTA	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.