Effects of Different Designs of Orthokeratology Lens on Myopia Control and Visual Quality

NCT05192824 | Unknown

• 1 other identifier: TianjinEH-Orthokeratology lens
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study was aimed to evaluate the effects of different Orthokeratology，including the size of central optical zone and the height of peripheral reverse curve, on myopia control and visual quality.

Conditions

Myopic Progression

Outcome Measures

Primary Outcomes (2)

• Changes in axial length in 2 years

  The axial length was measured by AL-scan

  Every 6 months for a period 2 years

• Changes in Cycloplegic subjective refraction in 2 years

  The cycloplegic subjective refraction was evaluated by optometrist

  Every 6 months for a period 2 years

Secondary Outcomes (9)

• Change in visual questionnaire as compared to baseline（Postoperative 6 months, 12 months, 18 months and 24 months）

  baseline, postoperative 6 months, 12 months, 18 months and 24 months

• Change in High-order aberrations (HOAs) in microns as compared to baseline(Postoperative 6 months, 12 months, 18 months and 24 months)

  baseline, postoperative 6 months, 12 months, 18 months and 24 months

• Change in contrast sensitivity as compared to baseline(Postoperative 6 months, 12 months, 18 months and 24 months）

  baseline, postoperative 6 months, 12 months, 18 months and 24 months

• Change in choroidal thickness captured by Optical Coherent Tomographer (OCT) as compared to baseline(Postoperative 6 months, 12 months, 18 months and 24 months）

  baseline, postoperative 6 months, 12 months, 18 months and 24 months

• Change in Corneal epithelial thickness captured by Optical Coherent Tomographer (OCT) as compared to baseline(Postoperative 6 months, 12 months, 18 months and 24 months）

  baseline, postoperative 6 months, 12 months, 18 months and 24 months

Study Arms (5)

Single-vision glasses

NO INTERVENTION

Subjects wearing single-vision glasses CR-39

Orthokeratology lenses group 1

EXPERIMENTAL

Subjects wearing orthokeratology lenses of 5mm optical zone.

Device: Orthokeratology lens

Orthokeratology lenses group 2

EXPERIMENTAL

Subjects wearing orthokeratology lenses of 5.5mm optical zone.

Device: Orthokeratology lens

Orthokeratology lenses group 3

EXPERIMENTAL

Subjects wearing orthokeratology lenses of 6mm optical zone.

Device: Orthokeratology lens

Orthokeratology lenses group 4

EXPERIMENTAL

Subjects wearing orthokeratology lenses of 6mm optical zone and the increased height of peripheral reverse curve.

Device: Orthokeratology lens

Interventions

Orthokeratology lens DEVICE

The intervention was according to the design of different optical zone and peripheral reverse curve

Also known as: Ortho-K

Orthokeratology lenses group 1; Orthokeratology lenses group 2; Orthokeratology lenses group 3; Orthokeratology lenses group 4

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Myopia: between -1.00D and 4.00D in both eyes
• Astigmatism: \<1.5D for with-the-rule astigmatism, \<1.00D for the against-the-rule astigmatism
• Visual acuity: the best corrected vision acuity(BCVA)≥20/20 in both eyes
• Subjects that volunteer to participate in the clinical trial and sign informed consent

You may not qualify if:

• Contraindications of wearing Ortho-K.
• Diagnosis of strabismus, amblyopia and other refractive development of the eye or systemic diseases.
• Any type of strabismus or amblyopia
• Systemic condition which might affect refractive development (for example, Down syndrome, Marfan's syndrome)
• Ocular conditions which might affect the refractive error (for example, cataract, ptosis)

Sponsors & Collaborators

• Tianjin Eye Hospital: lead

Study Sites (1)

Tianjin Eye Hospital

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

Related Publications (5)

• 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: 27464993 BACKGROUND

• Huang J, Wen D, Wang Q, McAlinden C, Flitcroft I, Chen H, Saw SM, Chen H, Bao F, Zhao Y, Hu L, Li X, Gao R, Lu W, Du Y, Jinag Z, Yu A, Lian H, Jiang Q, Yu Y, Qu J. Efficacy Comparison of 16 Interventions for Myopia Control in Children: A Network Meta-analysis. Ophthalmology. 2016 Apr;123(4):697-708. doi: 10.1016/j.ophtha.2015.11.010. Epub 2016 Jan 27.

  PMID: 26826749 BACKGROUND

• Hu Y, Wen C, Li Z, Zhao W, Ding X, Yang X. Areal summed corneal power shift is an important determinant for axial length elongation in myopic children treated with overnight orthokeratology. Br J Ophthalmol. 2019 Nov;103(11):1571-1575. doi: 10.1136/bjophthalmol-2018-312933. Epub 2019 Jan 31.

  PMID: 30705043 BACKGROUND

• Paune J, Fonts S, Rodriguez L, Queiros A. The Role of Back Optic Zone Diameter in Myopia Control with Orthokeratology Lenses. J Clin Med. 2021 Jan 18;10(2):336. doi: 10.3390/jcm10020336.

  PMID: 33477514 BACKGROUND

• Gifford P, Tran M, Priestley C, Maseedupally V, Kang P. Reducing treatment zone diameter in orthokeratology and its effect on peripheral ocular refraction. Cont Lens Anterior Eye. 2020 Feb;43(1):54-59. doi: 10.1016/j.clae.2019.11.006. Epub 2019 Nov 24.

  PMID: 31776061 BACKGROUND

Central Study Contacts

Shuxian Zhang, MD

CONTACT

+8618630996574; xindewo2006@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: January 14, 2022
• Study Start: December 10, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 14, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)