High MyopiaNCT05533450
A Study on the Efficacy and Safety of Multi-focal Scleral Contact Lens
A study testing Multi-focal rigid scleral contact lens and Rigid gas permeable contact lens in people with High Myopia, run by Shanghai Eye Disease Prevention and Treatment Center at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- High Myopia
- What is being tested?
- Multi-focal rigid scleral contact lens and Rigid gas permeable contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesChina
- Study dates
- 18 Oct 2022to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
- Best corrected visual acuity of both eyes ≥ 0.8.
Who cannot join
- 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.
- Any clinically significant active eye disease, such as glaucoma, uveitis, chorioretinitis, central retinal artery or vein occlusion, and so on.
- Patients with systemic diseases that may affect the wearing of hard contact lenses, such as hyperthyroidism, diabetes, mental illness, and so on.
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Shanghai Eye Disease Prevention & Treatment Center
Shanghai, Shanghai Municipality, 200040
Shanghai Eye Disease Prevention and Treatment Center
Shanghai, Shanghai Municipality, 200041
About this study
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
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.
- Conditions
- High Myopia
- Being tested
- Multi-focal rigid scleral contact lens, Rigid gas permeable contact lens
- Keywords
- high myopia, children and adolescents, defocus, scleral contact lens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-focal rigid scleral contact lensDevice
Also called OVCTEK
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.
Rigid gas permeable contact lensDevice
Also called OVCTEK
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.
| Study group | Role | What they receive |
|---|---|---|
| Multi-focal rigid scleral contact lens | Experimental | During the study period, subjects will wear a multi-focal rigid scleral contact lens daily. Receives: Device: Multi-focal rigid scleral contact lens |
| Rigid gas permeable contact lens | Active comparator | During the study period, the subjects will wear rigid contact lenses daily Receives: Device: Rigid gas permeable contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial length
Two-year change in axial length
Measured: 2 years
Secondary outcomes (1)
changes of spherical equivalent
Spherical equivalent as measured by cycloplegia autorefraction
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start18 Oct 2022 (estimated)
- Primary completion18 Oct 2022 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shandong University of Traditional Chinese Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05533450
- Sponsor's protocol ID
- kjb-gmj-v1.1-20220814
- Status last verified
- Oct 2022
- First submitted
- 5 Sep 2022
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05533450
- Acronym / sponsor ID
- kjb-gmj-v1.1-20220814
- Conditions
- High Myopia
- Keywords
- high myopia, children and adolescents, defocus, scleral contact lens
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Collaborators
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shandong University of Traditional Chinese Medicine
- Study start
- 18 Oct 2022 (estimated)
- Primary completion
- 18 Oct 2022 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 9 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-focal rigid scleral contact lens | Experimental | Device: Multi-focal rigid scleral contact lensDuring the study period, subjects will wear a multi-focal rigid scleral contact lens daily. |
| Rigid gas permeable contact lens | Active comparator | Device: Rigid gas permeable contact lensDuring the study period, the subjects will wear rigid contact lenses daily |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
- Best corrected visual acuity of both eyes ≥ 0.8.
Key exclusion criteria (5 listed)
- 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.
- Any clinically significant active eye disease, such as glaucoma, uveitis, chorioretinitis, central retinal artery or vein occlusion, and so on.
- Patients with systemic diseases that may affect the wearing of hard contact lenses, such as hyperthyroidism, diabetes, mental illness, and so on.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-focal rigid scleral contact lensAlso: OVCTEKTrue 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. | Device | Multi-focal rigid scleral contact lens |
| Rigid gas permeable contact lensAlso: OVCTEKRGP 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. | Device | Rigid gas permeable contact lens |
Primary outcome
Axial length
Time frame: 2 years
Two-year change in axial length
1 secondary outcome
changes of spherical equivalent
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-focal rigid scleral contact lens and Rigid gas permeable contact lens in people with High Myopia, run by Shanghai Eye Disease Prevention and Treatment Center at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axial length (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2022.