Myopia-control Efficacy by Peripheral Defocus Lens (PDL)
Study Details
Study Description
Brief 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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Control group The subjects are randomized to wear SV lens |
Device: Single vision lens
Wear single vision lens
|
| Experimental: experimental group +2D The subjects are randomized to wear special designed lens with +2D Peripheral Defocus. |
Device: +2D PDL
Wear Peripheral defocus lense with +2D
|
| Experimental: experimental group +3D The subjects are randomized to wear special designed lens with +3D Peripheral Defocus. |
Device: +3D PDL
Wear Peripheral defocus lense with +3D
|
| Experimental: experimental group +4D The subjects are randomized to wear special designed lens with +4D Peripheral Defocus. |
Device: +4D PDL
Wear Peripheral defocus lense with +4D
|
Outcome Measures
Primary Outcome Measures
- changes in cycloplegic objective spherical equivalent (SER) [baseline, 24 months]
changes in cycloplegic objective spherical equivalent (SER) from baseline between four groups.
Secondary Outcome Measures
- changes in ocular axial length [baseline, 24 months]
Changes in ocular axial length from baseline between four groups.
- visual performance [1 day]
The visual acuity of peripheral between four groups.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
Exclusion Criteria:
-
Strabismus
-
Ocular limitations
-
Systemic abnormalities affecting vision and ocular motility.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tianjin Eye Hospital | Tianjin | China | 300020 |
Sponsors and Collaborators
- Tianjin Eye Hospital
Investigators
- Principal Investigator: Lihua Li, Tianjin Eye Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TJYYLL-2018-04