Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07854366 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

SmoothCore Orthokeratology Plus M.O.V.E. Lenses vs. M.O.V.E. Lenses Alone for Myopia Control in Children With High Myopia

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint added 1 → 2 primary endpoints
See other at-risk trials from Beijing Tongren Hospital

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary endpoint(s) modified Show 4 more changesShow less
    • Start date pushed from Oct 1, 2026 to Oct 8, 2026
    • Eligibility criteria shortened, about 6 words
    • Secondary endpoints: 12 to 6
    • Study description shortened, about 176 words
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This clinical trial aims to determine whether a combination of overnight orthokeratology lenses and daytime myopia-control spectacles is more effective than myopia-control spectacles alone in slowing myopia progression and improving vision-related quality of life in children aged 8-14 years with high myopia. Orthokeratology lenses are contact lenses designed to temporarily reshape the anterior surface of the eye during sleep. The study will also asess the safety of this combined treatment.The main questions it seeks to answer are: * Does the combined treatment slow myopia progression over 12 months more effectively than myopia-control spectacles alone? * What ocular problems occur with each treatment, and how well do children adhere to the prescribed lens-wearing schedules? The researchers will compare SmoothCore orthokeratology lenses combined with M.O.V.E. myopia-control spectacle lenses with the same spectacle lenses used alone. A total of 100 children will be randomly assigned to one of the two groups, with an equal chance of being allocated to either group. Participants will: * Wear their assigned spectacle lenses for at least 10 hours per day for 12 months. Children in the combined-treatment group will also wear orthokeratology lenses for at least 8 hours per night on at least 5 nights per week. * Attend clinic visits at baseline and at 1 day, 1 week, and 1, 3, 6, and 12 months for scheduled eye examinations and measurements. * Keep a record of lens-wearing time and any eye discomfort, with assitance from a parent or guardian. * Complete questionnaires about vision-related daily activities and satisfaction with their lenses.
Trial Details
NCT Number NCT07854366
Lead Sponsor Beijing Tongren Hospital
Conditions
(from sponsor)
High Myopia
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov