Clinical trial NCT04618510: SEED-LVPEI Myopia Study
Official title: Efficacy of SEED's Novel Anti-myopia Contact Lens (Daily Disposable) in Controlling Myopia Progression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myopia
Keywords: Myopia
Contact Lens
Peripheral Defocus
Multi-focal
India
Extended Depth of Focus
Lead sponsor: L.V. Prasad Eye Institute
Sponsor class: OTHER
Collaborators: name: SEED Co. Ltd.
First posted: 2020-11-06
Enrollment: 108
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized clinical trial study aims to investigate the efficacy of novel SEED's EDOF based mid-lens design in controlling the myopia progression in

Indian children with these specific objectives:

1. To investigate the efficacy of SEED's 1-day pure extended depth of focus lenses controlling myopia progression in Indian children through a one-year randomized clinical study.
2. To investigate the role of SEED's 1-day pure extended depth of focus lenses in altering peripheral refraction of the eye to control myopia progression.
3. To determine if there is any specific cohort that shows better efficacy in myopia control with 1-day pure extended depth of focus lenses based on central and peripheral optics (degree of myopia and optical parameters).
4. To investigate the qualitative assessment of comfort and visual experience with the SEED's EDOF contact lenses through the questionnaire method.

Detailed description: This prospective randomized controlled clinical trial will be conducted in Myopia Research Lab, L V Prasad Eye Institute, Hyderabad and the study protocol will adhere to the tenets of the Declaration of Helsinki. Participants will be recruited through advertisements in local print media (newspaper), approaching schools, through clinical referrals. Children will be assigned to either the control group or intervention group randomly based on computer-generated random numbers operated by the investigator. All participants will undergo a cycloplegic refractive error assessment after the instillation of tropicamide 1% eye drops (or cyclopentolate 1% eye drops in case of varying refractive error between objective and subjective values). Axial length and cycloplegic refractive measurements will be taken with using Lenstar LS900 biometer and Shin- Nippon autorefractor respectively for scheduled follow up and will be compared with the baseline parameters.

Eligibility criteria: Inclusion Criteria:

* Myopia (SE) between -0.50D to -10.00D
* Astigmatism less than 0.75D
* Anisometropia less than 1.00D
* Age of the participant from 7 to 15 years
* Neophyte or existing soft contact lens wearer
* Best-corrected visual acuity (BCVA); ≤ 20/20
* Participants who are willing to wear the contact lens constantly

Exclusion Criteria:

* Participants who had any ocular or systemic conditions that could influence the refractive error
* Poor compliance of contact lenses from existing wearer
* Prior use of orthokeratology lenses/bifocal lenses/anti-myopia strategies
* Participants who had any medications that could influence the refractive error

Primary outcomes:
measure: Central refractive error changes
timeFrame: Data will be collected at baseline, 3 months, 6 months and 12 months.
measure: Axial length changes
timeFrame: Data will be collected at baseline, 3 months, 6 months and 12 months.
measure: Peripheral refractive error changes
timeFrame: Data will be collected at baseline, 3 months, 6 months and 12 months.
Secondary outcomes:
measure: Qualitative assessment
timeFrame: Data will be collected at 3 months, 6 months and 12 months.
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Pavan K. Verkicharla
state: Telangana
Study officials:
affiliation: L.V. Prasad Eye Institute
name: Pavan K Verkicharla, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sankaridurg P, Holden B, Smith E 3rd, Naduvilath T, Chen X, de la Jara PL, Martinez A, Kwan J, Ho A, Frick K, Ge J. Decrease in rate of myopia progression with a contact lens designed to reduce relative peripheral hyperopia: one-year results. Invest Ophthalmol Vis Sci. 2011 Dec 9;52(13):9362-7. doi: 10.1167/iovs.11-7260.
citation: Bakaraju RC, Ehrmann K, Ho A. Extended depth of focus contact lenses vs. two commercial multifocals: Part 1. Optical performance evaluation via computed through-focus retinal image quality metrics. J Optom. 2018 Jan-Mar;11(1):10-20. doi: 10.1016/j.optom.2017.04.003. Epub 2017 Jun 9.
citation: Bakaraju RC, Tilia D, Sha J, Diec J, Chung J, Kho D, Delaney S, Munro A, Thomas V. Extended depth of focus contact lenses vs. two commercial multifocals: Part 2. Visual performance after 1 week of lens wear. J Optom. 2018 Jan-Mar;11(1):21-32. doi: 10.1016/j.optom.2017.04.001. Epub 2017 Jun 12.
citation: Sankaridurg P, Bakaraju RC, Naduvilath T, Chen X, Weng R, Tilia D, Xu P, Li W, Conrad F, Smith EL 3rd, Ehrmann K. Myopia control with novel central and peripheral plus contact lenses and extended depth of focus contact lenses: 2 year results from a randomised clinical trial. Ophthalmic Physiol Opt. 2019 Jul;39(4):294-307. doi: 10.1111/opo.12621. Epub 2019 Jun 10.