Myopia, ProgressiveNCT05373693
Myopia-control Efficacy by Peripheral Defocus Lens (PDL)
A study testing Single vision lens, +2D PDL and +3D PDL in people with Myopia, Progressive, run by Tianjin Eye Hospital at 1 site in China.
Trial summary
The proposed study below aims to assess the effect of customized Bestivue PDL lenses on retinal image quality and myopia control. A total of 160 subjected would be enrolled in and randomized to allcoate into four groups. Read more about this study
- Who is it for?
- Ages 6 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Progressive
- What is being tested?
- Single vision lens, +2D PDL and +3D PDL
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2019to 30 Sep 2022
- 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 6 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The subjects had spherical RE of -1.00 to -6.00 D
- Astigmatism ≤ 4.00 D
- Anisometropia ≤ 1.50 D\
- Best corrected visual acuity (BCVA) equal to or better than logMAR 0.0 (20/20) in both eyes.
Who cannot join
- Strabismus
- Ocular limitations
- Systemic abnormalities affecting vision and ocular motility.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Visual Performance and Myopia-control Efficacy Afforded by Bestivue Peripheral Defocus Lens (PDL)
The proposed study below aims to assess the effect of customized Bestivue PDL lenses on retinal image quality and myopia control. A total of 160 subjected would be enrolled in and randomized to allcoate into four groups. Visual acuity and image blur at various gaze directions and eccentricities on children fitted with +2 to 4 D power and single vision lenses would be measured to assess the short term effect of PDL lens. Axial length and cycloplegic objective refractive error would be measured to assess the Myopia-control Efficacy.
Read the detailed description
The proposed study below aims to assess the short-term and long-term effect of customized Bestivue PDL lenses on retinal image quality and myopia control. To these ends, two stages of testing are planned. First, objective testing will be utilized to assess the effect of Bestivue PDL lenses on visual acuity and image blur at various gaze directions and eccentricities on 4- to 13-year-old children fitted with +2 to 4 D power and single vision lenses.In the second stage, the same children participants will wear either single or Bestvue PDL lenses with one of the four plus power designs for 2 years. Their corrected visual acuity, objective refractive error with dilation and axial length will be assessed for each eye every six months for two years. Outcomes of these studies should inform whether Bestivue PDL lenses are effective in myopia control while affording adequate visual comfort and performance.
- Conditions
- Myopia, Progressive
- Being tested
- Single vision lens, +2D PDL, +3D PDL, +4D PDL
- Medical subject headings
- Myopia, Degenerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single vision lensDevice
Wear single vision lens
+2D PDLDevice
Wear Peripheral defocus lense with +2D
+3D PDLDevice
Wear Peripheral defocus lense with +3D
+4D PDLDevice
Wear Peripheral defocus lense with +4D
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | The subjects are randomized to wear SV lens Receives: Device: Single vision lens |
| experimental group +2D | Experimental | The subjects are randomized to wear special designed lens with +2D Peripheral Defocus. Receives: Device: +2D PDL |
| experimental group +3D | Experimental | The subjects are randomized to wear special designed lens with +3D Peripheral Defocus. Receives: Device: +3D PDL |
| experimental group +4D | Experimental | The subjects are randomized to wear special designed lens with +4D Peripheral Defocus. Receives: Device: +4D PDL |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in cycloplegic objective spherical equivalent (SER)
changes in cycloplegic objective spherical equivalent (SER) from baseline between four groups.
Measured: baseline, 24 months
Secondary outcomes (2)
changes in ocular axial length
Changes in ocular axial length from baseline between four groups.
Measured: baseline, 24 months
visual performance
The visual acuity of peripheral between four groups.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start1 Jul 2019
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopia, ProgressiveStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lihua Li, Principal investigator, Tianjin Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373693
- Sponsor's protocol ID
- TJYYLL-2018-04
- Status last verified
- Mar 2022
- First submitted
- 15 Apr 2022
- Last updated
- 13 May 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Visual Performance and Myopia-control Efficacy Afforded by Bestivue Peripheral Defocus Lens (PDL)
- ClinicalTrials.gov ID
- NCT05373693
- Acronym / sponsor ID
- TJYYLL-2018-04
- Conditions
- Myopia, Progressive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Tianjin Eye HospitalUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 13 May 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 proposed study below aims to assess the effect of customized Bestivue PDL lenses on retinal image quality and myopia control. A total of 160 subjected would be enrolled in and randomized to allcoate into four groups. Visual acuity and image blur at various gaze directions and eccentricities on children fitted with +2 to 4 D power and single vision lenses would be measured to assess the short term effect of PDL lens. Axial length and cycloplegic objective refractive error would be measured to assess the Myopia-control Efficacy.
Detailed description
The proposed study below aims to assess the short-term and long-term effect of customized Bestivue PDL lenses on retinal image quality and myopia control. To these ends, two stages of testing are planned. First, objective testing will be utilized to assess the effect of Bestivue PDL lenses on visual acuity and image blur at various gaze directions and eccentricities on 4- to 13-year-old children fitted with +2 to 4 D power and single vision lenses.In the second stage, the same children participants will wear either single or Bestvue PDL lenses with one of the four plus power designs for 2 years. Their corrected visual acuity, objective refractive error with dilation and axial length will be assessed for each eye every six months for two years. Outcomes of these studies should inform whether Bestivue PDL lenses are effective in myopia control while affording adequate visual comfort and performance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Device: Single vision lensThe subjects are randomized to wear SV lens |
| experimental group +2D | Experimental | Device: +2D PDLThe subjects are randomized to wear special designed lens with +2D Peripheral Defocus. |
| experimental group +3D | Experimental | Device: +3D PDLThe subjects are randomized to wear special designed lens with +3D Peripheral Defocus. |
| experimental group +4D | Experimental | Device: +4D PDLThe subjects are randomized to wear special designed lens with +4D Peripheral Defocus. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- The subjects had spherical RE of -1.00 to -6.00 D
- Astigmatism ≤ 4.00 D
- Anisometropia ≤ 1.50 D\
- Best corrected visual acuity (BCVA) equal to or better than logMAR 0.0 (20/20) in both eyes.
Key exclusion criteria (3 listed)
- Strabismus
- Ocular limitations
- Systemic abnormalities affecting vision and ocular motility.
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 |
|---|---|---|
| Single vision lensWear single vision lens | Device | Control group |
| +2D PDLWear Peripheral defocus lense with +2D | Device | experimental group +2D |
| +3D PDLWear Peripheral defocus lense with +3D | Device | experimental group +3D |
| +4D PDLWear Peripheral defocus lense with +4D | Device | experimental group +4D |
Primary outcome
changes in cycloplegic objective spherical equivalent (SER)
Time frame: baseline, 24 months
changes in cycloplegic objective spherical equivalent (SER) from baseline between four groups.
2 secondary outcomes
changes in ocular axial length
Time frame: baseline, 24 months
visual performance
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 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.
Lihua Li principal investigator
Tianjin Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single vision lens, +2D PDL and +3D PDL in people with Myopia, Progressive, run by Tianjin Eye Hospital at 1 site 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 4 inclusion and 3 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 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
changes in cycloplegic objective spherical equivalent (SER) (time frame: baseline, 24 months). 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 13 May 2022.