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

Primary Purpose

Myopic Progression

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Orthokeratology lens
Sponsored by
Tianjin Eye Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopic Progression

Eligibility Criteria

8 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

  • Tianjin Eye HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

No Intervention

Experimental

Experimental

Experimental

Experimental

Arm Label

Single-vision glasses

Orthokeratology lenses group 1

Orthokeratology lenses group 2

Orthokeratology lenses group 3

Orthokeratology lenses group 4

Arm Description

Subjects wearing single-vision glasses CR-39

Subjects wearing orthokeratology lenses of 5mm optical zone.

Subjects wearing orthokeratology lenses of 5.5mm optical zone.

Subjects wearing orthokeratology lenses of 6mm optical zone.

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

Outcomes

Primary Outcome Measures

Changes in axial length in 2 years
The axial length was measured by AL-scan
Changes in Cycloplegic subjective refraction in 2 years
The cycloplegic subjective refraction was evaluated by optometrist

Secondary Outcome Measures

Change in visual questionnaire as compared to baseline（Postoperative 6 months, 12 months, 18 months and 24 months）
The symptoms score measured by a visual questionnaire, each symptom was evaluated on a scale of 0 to 10.
Change in High-order aberrations (HOAs) in microns as compared to baseline(Postoperative 6 months, 12 months, 18 months and 24 months)
Ocular aberration measured by Zeiss i. Profiler Plus aberrometer
Change in contrast sensitivity as compared to baseline(Postoperative 6 months, 12 months, 18 months and 24 months）
Contrast sensitivity measured by Stereo optical 6500
Change in choroidal thickness captured by Optical Coherent Tomographer (OCT) as compared to baseline(Postoperative 6 months, 12 months, 18 months and 24 months）
choroidal thickness captured by Optical Coherent Tomographer (OCT) and measured using a customized software
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）
Corneal epithelial thickness captured by Optical Coherent Tomographer (OCT) customized software
Change in corneal biomechanics parameters (SSI) as compared to baseline (Postoperative 6 months, 12 months, 18 months and 24 months）
Corneal response parameters(SSI) was evaluated by Corvis ST.
Change in peripheral refraction as compared to baseline (Postoperative 6 months, 12 months, 18 months and 24 months）
Peripheral refraction measured by multispectral refraction topography
Change in corneal surface regularity index (SRI) as compared to baseline (Postoperative 6 months, 12 months, 18 months and 24 months）
The corneal surface regularity index (SRI) was measured by Corneal Topography.
Change in corneal surface asymmetry index (SAI) as compared to baseline (Postoperative 6 months, 12 months, 18 months and 24 months）
The corneal surface asymmetry index (SAI) was measured by Corneal Topography.

Full Information

First Posted
November 19, 2021
Last Updated
December 30, 2021
Sponsor
Tianjin Eye Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05192824
Brief Title
Effects of Different Designs of Orthokeratology Lens on Myopia Control and Visual Quality
Official Title
Effects of Different Designs of Orthokeratology Lens on Myopia Control and Visual Quality
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 10, 2021 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tianjin Eye Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This study was aimed to evaluate the effects of different Orthokeratology on myopia control and visual quality. The different optical zone of Orthokeratology lens was divided into 4 groups, ranged from 5.5 mm to 6 mm. And the control group subjects with the single glasses was included. The effectiveness of Orthokeratology was measured by axial length progression. The visual quality of subjects was evaluated by a questionnaire, contrast sensitivity and wavefront aberration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopic Progression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single-vision glasses
Arm Type
No Intervention
Arm Description
Subjects wearing single-vision glasses CR-39
Arm Title
Orthokeratology lenses group 1
Arm Type
Experimental
Arm Description
Subjects wearing orthokeratology lenses of 5mm optical zone.
Arm Title
Orthokeratology lenses group 2
Arm Type
Experimental
Arm Description
Subjects wearing orthokeratology lenses of 5.5mm optical zone.
Arm Title
Orthokeratology lenses group 3
Arm Type
Experimental
Arm Description
Subjects wearing orthokeratology lenses of 6mm optical zone.
Arm Title
Orthokeratology lenses group 4
Arm Type
Experimental
Arm Description
Subjects wearing orthokeratology lenses of 6mm optical zone and the increased height of peripheral reverse curve.
Intervention Type
Device
Intervention Name(s)
Orthokeratology lens
Other Intervention Name(s)
Ortho-K
Intervention Description
The intervention was according to the design of different optical zone and peripheral reverse curve
Primary Outcome Measure Information:
Title
Changes in axial length in 2 years
Description
The axial length was measured by AL-scan
Time Frame
Every 6 months for a period 2 years
Title
Changes in Cycloplegic subjective refraction in 2 years
Description
The cycloplegic subjective refraction was evaluated by optometrist
Time Frame
Every 6 months for a period 2 years
Secondary Outcome Measure Information:
Title
Change in visual questionnaire as compared to baseline（Postoperative 6 months, 12 months, 18 months and 24 months）
Description
The symptoms score measured by a visual questionnaire, each symptom was evaluated on a scale of 0 to 10.
Time Frame
baseline, postoperative 6 months, 12 months, 18 months and 24 months
Title
Change in High-order aberrations (HOAs) in microns as compared to baseline(Postoperative 6 months, 12 months, 18 months and 24 months)
Description
Ocular aberration measured by Zeiss i. Profiler Plus aberrometer
Time Frame
baseline, postoperative 6 months, 12 months, 18 months and 24 months
Title
Change in contrast sensitivity as compared to baseline(Postoperative 6 months, 12 months, 18 months and 24 months）
Description
Contrast sensitivity measured by Stereo optical 6500
Time Frame
baseline, postoperative 6 months, 12 months, 18 months and 24 months
Title
Change in choroidal thickness captured by Optical Coherent Tomographer (OCT) as compared to baseline(Postoperative 6 months, 12 months, 18 months and 24 months）
Description
choroidal thickness captured by Optical Coherent Tomographer (OCT) and measured using a customized software
Time Frame
baseline, postoperative 6 months, 12 months, 18 months and 24 months
Title
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）
Description
Corneal epithelial thickness captured by Optical Coherent Tomographer (OCT) customized software
Time Frame
baseline, postoperative 6 months, 12 months, 18 months and 24 months
Title
Change in corneal biomechanics parameters (SSI) as compared to baseline (Postoperative 6 months, 12 months, 18 months and 24 months）
Description
Corneal response parameters(SSI) was evaluated by Corvis ST.
Time Frame
baseline, postoperative 6 months, 12 months, 18 months and 24 months
Title
Change in peripheral refraction as compared to baseline (Postoperative 6 months, 12 months, 18 months and 24 months）
Description
Peripheral refraction measured by multispectral refraction topography
Time Frame
baseline, postoperative 6 months, 12 months, 18 months and 24 months
Title
Change in corneal surface regularity index (SRI) as compared to baseline (Postoperative 6 months, 12 months, 18 months and 24 months）
Description
The corneal surface regularity index (SRI) was measured by Corneal Topography.
Time Frame
baseline, postoperative 6 months, 12 months, 18 months and 24 months
Title
Change in corneal surface asymmetry index (SAI) as compared to baseline (Postoperative 6 months, 12 months, 18 months and 24 months）
Description
The corneal surface asymmetry index (SAI) was measured by Corneal Topography.
Time Frame
baseline, postoperative 6 months, 12 months, 18 months and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shuxian Zhang, MD
Phone
+8618630996574
Email
xindewo2006@163.com
Facility Information:
Facility Name
Tianjin Eye Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuxian Zhang
Phone
+8618630996574
Email
xindewo2006@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27464993
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.
Results Reference
background
PubMed Identifier
26826749
Citation
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.
Results Reference
background
PubMed Identifier
30705043
Citation
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.
Results Reference
background
PubMed Identifier
33477514
Citation
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.
Results Reference
background
PubMed Identifier
31776061
Citation
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.
Results Reference
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Effects of Different Designs of Orthokeratology Lens on Myopia Control and Visual Quality

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