Back to resultsA Study on the Efficacy and Safety of Multi-focal Scleral Contact Lens
Primary Purpose
High Myopia
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Multi-focal rigid scleral contact lens
Rigid gas permeable contact lens
Sponsored by
About this trial
This is an interventional treatment trial for High Myopia focused on measuring high myopia, children and adolescents, defocus, scleral contact lens
Eligibility Criteria
Inclusion Criteria:
- Be able to understand and sign the informed consent when accompanied by parents or guardians.
- Age from 8 years old to15 years old.
- The equivalent spherical lens of both eyes after ciliary muscle paralysis is -5.00D to -20.00D, the astigmatism is ≤-3.50D.
- Willing to wear hard contact lenses, and able to wear only the hard contact lenses provided by the study as required and ensure adequate wearing duration.
(6) Best corrected visual acuity of both eyes ≥ 0.8.
Exclusion Criteria:
(1) Allergic or intolerant to rigid contact lens or its care products or ciliary muscle paralysis drugs.
Strabismus and/or amblyopia. (3) Those who have worn hard contact lenses in the past 30 days are using atropine, defocus frame lens, bifocal lens or progressive lens, acupuncture, etc. for myopia treatment.
(4) Any clinically significant active eye disease, such as glaucoma, uveitis, chorioretinitis, central retinal artery or vein occlusion, and so on.
(5) Patients with systemic diseases that may affect the wearing of hard contact lenses, such as hyperthyroidism, diabetes, mental illness, and so on.
(6) are using drugs that affect their eye health. (7) History of eye injury or surgery. (8) Incapacitated or unable to follow the visitor as required. (9) Other conditions not suitable for inclusion as judged by the investigator.
Sites / Locations
- Shanghai Eye Disease Prevention & Treatment Center
- Shanghai Eye Disease Prevention and Treatment Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Multi-focal rigid scleral contact lens
Rigid gas permeable contact lens
Arm Description
During the study period, subjects will wear a multi-focal rigid scleral contact lens daily.
During the study period, the subjects will wear rigid contact lenses daily
Outcomes
Primary Outcome Measures
Axial length
Two-year change in axial length
Secondary Outcome Measures
changes of spherical equivalent
Spherical equivalent as measured by cycloplegia autorefraction
Full Information
NCT ID
NCT05533450
First Posted
September 5, 2022
Last Updated
October 17, 2022
Sponsor
Shanghai Eye Disease Prevention and Treatment Center
Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shandong University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05533450
Brief Title
A Study on the Efficacy and Safety of Multi-focal Scleral Contact Lens
Official Title
A Multicenter Randomized Controlled Study on the Efficacy and Safety of Multi-focal Scleral Contact Lens in the Treatment of Ultra-high Myopia in Children and Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 18, 2022 (Anticipated)
Primary Completion Date
October 18, 2022 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Eye Disease Prevention and Treatment Center
Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shandong University of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The rigid scleral contact lens with optical multi-focal design adopted in this study can focus the light in part of the optical area on the front of the retina to form myopic defocus, in order to delay the axial changes in children and adolescents with ultra-high myopia. In this study, RGP was used as a control, and a multicenter, randomized, controlled trial was conducted to verify the safety and effectiveness of multifocal scleral contact lenses for the correction of ultra-high myopia in children and adolescents.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Myopia
Keywords
high myopia, children and adolescents, defocus, scleral contact lens
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Multi-focal rigid scleral contact lens
Arm Type
Experimental
Arm Description
During the study period, subjects will wear a multi-focal rigid scleral contact lens daily.
Arm Title
Rigid gas permeable contact lens
Arm Type
Active Comparator
Arm Description
During the study period, the subjects will wear rigid contact lenses daily
Intervention Type
Device
Intervention Name(s)
Multi-focal rigid scleral contact lens
Other Intervention Name(s)
OVCTEK
Intervention Description
True scleral lenses rest on the sclera and do not touch the cornea and limbus, leaving a clear area between the contact lens and the cornea.
Intervention Type
Device
Intervention Name(s)
Rigid gas permeable contact lens
Other Intervention Name(s)
OVCTEK
Intervention Description
RGP contact lens is designed from a special rigid hydrophobic material. Patients wear RGP contact lens to form a "contact lens-tear-cornea" system to correct irregular astigmatism, reduce aberrations, provide good visual quality, and control the development of the disease through mild "shaping" effect.
Primary Outcome Measure Information:
Title
Axial length
Description
Two-year change in axial length
Time Frame
2 years
Secondary Outcome Measure Information:
Title
changes of spherical equivalent
Description
Spherical equivalent as measured by cycloplegia autorefraction
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Be able to understand and sign the informed consent when accompanied by parents or guardians.
Age from 8 years old to15 years old.
The equivalent spherical lens of both eyes after ciliary muscle paralysis is -5.00D to -20.00D, the astigmatism is ≤-3.50D.
Willing to wear hard contact lenses, and able to wear only the hard contact lenses provided by the study as required and ensure adequate wearing duration.
(6) Best corrected visual acuity of both eyes ≥ 0.8.
Exclusion Criteria:
(1) Allergic or intolerant to rigid contact lens or its care products or ciliary muscle paralysis drugs.
Strabismus and/or amblyopia. (3) Those who have worn hard contact lenses in the past 30 days are using atropine, defocus frame lens, bifocal lens or progressive lens, acupuncture, etc. for myopia treatment.
(4) Any clinically significant active eye disease, such as glaucoma, uveitis, chorioretinitis, central retinal artery or vein occlusion, and so on.
(5) Patients with systemic diseases that may affect the wearing of hard contact lenses, such as hyperthyroidism, diabetes, mental illness, and so on.
(6) are using drugs that affect their eye health. (7) History of eye injury or surgery. (8) Incapacitated or unable to follow the visitor as required. (9) Other conditions not suitable for inclusion as judged by the investigator.
Facility Information:
Facility Name
Shanghai Eye Disease Prevention & Treatment Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Shanghai Eye Disease Prevention and Treatment Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200041
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study on the Efficacy and Safety of Multi-focal Scleral Contact Lens
We'll reach out to this number within 24 hrs