MyopiaSLIMSNCT04618510
SEED-LVPEI Myopia Study
A study testing SEED 1-dayPure EDOF soft contact lens and Single Vision Spectacles in people with Myopia, run by L.V. Prasad Eye Institute at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- SEED 1-dayPure EDOF soft contact lens and Single Vision Spectacles
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteIndia
- Study dates
- 11 Dec 2020to 30 Aug 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 7 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of SEED's Novel Anti-myopia Contact Lens (Daily Disposable) in Controlling Myopia Progression
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:
- 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.
- 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.
- 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).
- To investigate the qualitative assessment of comfort and visual experience with the SEED's EDOF contact lenses through the questionnaire method.
Read the 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.
- Conditions
- Myopia
- Being tested
- SEED 1-dayPure EDOF soft contact lens, Single Vision Spectacles
- Keywords
- Myopia, Contact Lens, Peripheral Defocus, Multi-focal, India, Extended Depth of Focus
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEED 1-dayPure EDOF soft contact lensDevice
Centre-distance contact lens with peripheral add power working on extended depth of focus principle to control myopia
Single Vision SpectaclesDevice
These are the type of glasses that correct vision for a single distance
| Study group | Role | What they receive |
|---|---|---|
| SEED 1-dayPure EDOF soft contact lens | Experimental | The participant will be requested to wear the daily disposable lens 8-10 hours per day and replaced daily. All participants will be followed for 12 months (followup visit schedule; 3 months, 6 months, 12 months) post-contact lens wear. Receives: Device: SEED 1-dayPure EDOF soft contact lens |
| Single vision spectacle lens | Sham comparator | The participant will be requested to wear the spectacle lens daily. All participants will be followed for 12 months (follow up visit schedule; 3 months, 6 months, 12 months) post spectacle lens wear. Receives: Device: Single Vision Spectacles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central refractive error changes
- Changes (1 year) in spherical equivalent refractive error (dioptre) in the intervention and control group from the baseline.
- Changes (1 year) in spherical equivalent refractive error (dioptre) among different degrees of myopia in the intervention and control group from the baseline.
Measured: Data will be collected at baseline, 3 months, 6 months and 12 months.
Axial length changes
- Changes (1 year) in axial length (millimetre) in the intervention and control group from the baseline.
- Changes (1 year) in axial length (millimetre) among different degrees of myopia in the intervention and control group from the baseline.
Measured: Data will be collected at baseline, 3 months, 6 months and 12 months.
Peripheral refractive error changes
- Changes (1 year) in peripheral spherical equivalent refractive error (dioptre) of the individuals in the intervention and control group from the baseline.
- Changes (1 year) in peripheral spherical equivalent refractive error (dioptre) among different degrees of myopia in the intervention and control group from the baseline.
Measured: Data will be collected at baseline, 3 months, 6 months and 12 months.
Secondary outcomes (1)
Qualitative assessment
Qualitative assessment of discomfort and visual experience of centre-distance multifocal contact lens will be measured on a scale of 0-4 (0=Never, 1=Rarely, 2=Sometimes, 3=Often, 4=Always).
Measured: Data will be collected at 3 months, 6 months and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start11 Dec 2020
- Primary completion30 Aug 2021
- Study completion30 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- L.V. Prasad Eye Institute
- Sponsor type
- University, hospital or other
- Collaborators
- SEED Co. Ltd.
- Responsible party
- Principal investigator, Dr. Pavan Verkicharla, L.V. Prasad Eye Institute
- Investigators
- Pavan K Verkicharla, PhD, Principal investigator, L.V. Prasad Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618510
- Sponsor's protocol ID
- LEC-BHR-P-09-20-511
- Acronym
- SLIMS
- Status last verified
- Sep 2021
- First submitted
- 27 Oct 2020
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22039230Bakaraju 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.
PubMed 28606456Bakaraju 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.
PubMed 28619486Sankaridurg 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.
PubMed 31180155Manoharan MK, Verkicharla PK. Randomised clinical trial of extended depth of focus lenses for controlling myopia progression: Outcomes from SEED LVPEI Indian Myopia Study. Br J Ophthalmol. 2024 Aug 22;108(9):1292-1298. doi: 10.1136/bjo-2023-323651.
PubMed 38604622
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of SEED's Novel Anti-myopia Contact Lens (Daily Disposable) in Controlling Myopia Progression
- ClinicalTrials.gov ID
- NCT04618510
- Acronym / sponsor ID
- SLIMS / LEC-BHR-P-09-20-511
- Conditions
- Myopia
- Keywords
- Myopia, Contact Lens, Peripheral Defocus, Multi-focal, India, Extended Depth of Focus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (actual)
- Lead sponsor
- L.V. Prasad Eye InstituteUniversity, hospital or other
- Collaborators
- SEED Co. Ltd.
- Study start
- 11 Dec 2020 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2022 (estimated)
- First posted
- 6 Nov 2020 (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.
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:
- 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.
- 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.
- 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).
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SEED 1-dayPure EDOF soft contact lens | Experimental | Device: SEED 1-dayPure EDOF soft contact lensThe participant will be requested to wear the daily disposable lens 8-10 hours per day and replaced daily. All participants will be followed for 12 months (followup visit schedule; 3 months, 6 months, 12 months) post-contact lens wear. |
| Single vision spectacle lens | Sham comparator | Device: Single Vision SpectaclesThe participant will be requested to wear the spectacle lens daily. All participants will be followed for 12 months (follow up visit schedule; 3 months, 6 months, 12 months) post spectacle lens wear. |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| SEED 1-dayPure EDOF soft contact lensCentre-distance contact lens with peripheral add power working on extended depth of focus principle to control myopia | Device | SEED 1-dayPure EDOF soft contact lens |
| Single Vision SpectaclesThese are the type of glasses that correct vision for a single distance | Device | Single vision spectacle lens |
Primary outcome
Central refractive error changes
Time frame: Data will be collected at baseline, 3 months, 6 months and 12 months.
1. Changes (1 year) in spherical equivalent refractive error (dioptre) in the intervention and control group from the baseline. 2. Changes (1 year) in spherical equivalent refractive error (dioptre) among different degrees of myopia in the intervention and control group from the baseline.
Axial length changes
Time frame: Data will be collected at baseline, 3 months, 6 months and 12 months.
1. Changes (1 year) in axial length (millimetre) in the intervention and control group from the baseline. 2. Changes (1 year) in axial length (millimetre) among different degrees of myopia in the intervention and control group from the baseline.
Peripheral refractive error changes
Time frame: Data will be collected at baseline, 3 months, 6 months and 12 months.
1. Changes (1 year) in peripheral spherical equivalent refractive error (dioptre) of the individuals in the intervention and control group from the baseline. 2. Changes (1 year) in peripheral spherical equivalent refractive error (dioptre) among different degrees of myopia in the intervention and control group from the baseline.
1 secondary outcome
Qualitative assessment
Time frame: Data will be collected at 3 months, 6 months and 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
- Background: PubMed 22039230Sankaridurg 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.
- Background: PubMed 28606456Bakaraju 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.
- Background: PubMed 28619486Bakaraju 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.
- Background: PubMed 31180155Sankaridurg 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.
- Derived from this study: PubMed 38604622Manoharan MK, Verkicharla PK. Randomised clinical trial of extended depth of focus lenses for controlling myopia progression: Outcomes from SEED LVPEI Indian Myopia Study. Br J Ophthalmol. 2024 Aug 22;108(9):1292-1298. doi: 10.1136/bjo-2023-323651.
- Individual participant dataSharing planned: No
Related trials for Myopia
RecruitingPhase 3
A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control
Myopia
Recruiting
Evaluation of Orthokeratology Lenses With a 5MM Optic Zone Diameter
Myopia, Astigmatism
Recruiting
Wavelength Intervention for Nearsighted Kids
Myopia
Not yet recruiting
SmoothCore Orthokeratology Plus M.O.V.E. Lenses vs. M.O.V.E. Lenses Alone for Myopia Control in Children With High Myopia
High Myopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
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.
Pavan K Verkicharla, PhD principal investigator
L.V. Prasad Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SEED 1-dayPure EDOF soft contact lens and Single Vision Spectacles in people with Myopia, run by L.V. Prasad Eye Institute at 1 site in India.
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 7 inclusion and 4 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 24 Sep 2021. 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 India. 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?
Central refractive error changes (time frame: Data will be collected at baseline, 3 months, 6 months and 12 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04618510, which also lists 5 linked publications.
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 24 Sep 2021; AzTrials last refreshed its copy on 27 Oct 2026.