Using special spectacle films to slow down myopia in children

Spectacle Films Utilising S.T.O.P.® Technology for Slowing Down Myopia Progression in Children: A Prospective, Masked, Controlled, Randomised, Clinical Trial.

This study is testing if special spectacle films can help slow down worsening eyesight in children aged 6 to 14.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 210 (estimated)
• Ages: 6 Years to 14 Years
• Sex: All
• Sponsor: nthalmic Pty Ltd (Research network)
• Locations: 5 sites (Tianjin, Heping District and 4 other locations)
• Trial ID: NCT06137560 on ClinicalTrials.gov

What this trial studies

This trial aims to evaluate the effectiveness of spectacle films utilizing Spatio Temporal Optic Phase (S.T.O.P.®) technology in slowing myopia progression in children aged 6-14. Participants will be randomly assigned to wear different types of spectacle lenses, including standard single vision lenses and those enhanced with S.T.O.P.® films that provide either dynamic or static optical cues. The study will be conducted over approximately 42 months, with regular follow-up visits to assess myopia progression. The trial includes two parts: the first compares the rate of progression between different lens options, while the second focuses on the best-performing option against a static cue.

Who should consider this trial

Good fit: Ideal candidates are children aged 6-14 who are myopic and can comply with the study's requirements.

Not a fit: Patients with severe myopia or those unable to wear spectacles for the required duration may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the progression of myopia in children, potentially improving their long-term vision health.

How similar studies have performed: While the use of dynamic optical cues in myopia management is a novel approach, similar studies have shown promise in addressing myopia progression.

Eligibility criteria

Inclusion Criteria:

* Be between 6-14 years inclusive at time of enrolment.
* Have:

  * Read the Informed Assent.
  * Been explained the Informed Assent.
  * Indicated an understanding of the Informed Assent.
  * Signed the Informed Assent.
* Have their parent / legal guardian:

  * Read the Informed Consent.
  * Been explained the Informed Consent.
  * Indicated an understanding of the Informed Consent.
  * Signed the Informed Consent.
* Along with their parent / legal guardian, be capable of comprehending the nature of the study, and be willing and able to adhere to study requirements.
* Along with their parent / legal guardian, agree to maintain the visit and prescribed wearing schedule.
* Agree to wear allocated spectacles for a minimum of 5 days per week, at least 6 hours per day for the duration of the study and to inform the investigator if their schedule is interrupted.
* Possess wearable and visually functioning spectacles.
* Be in good general health, based on the parent's / legal guardian's knowledge.
* Have best-corrected high contrast visual acuity based on manifest refraction of 0.10 logMAR (20/25, 6/7.6) or better in each eye.
* Meet the following criteria determined by cycloplegic autorefraction at Baseline:

  * -5.00 D ≤ spherical equivalent ≤ -0.75 D and sphere component ≤ -0.50 DS.
  * -1.50 DC ≤ astigmatic component ≤ 0 DC.
  * \|Spherical equivalent anisometropia\| ≤ 1.00 D.

Exclusion Criteria:

* Participant is currently, or within 30 days prior to this study, has been an active participant in another study.
* Current or prior use of ANY form of myopia control, including but not limited to:

  * Optical devices:

    * Bifocal or multifocal spectacles of any type.
    * Bifocal or multifocal contact lenses of any type.
    * Orthokeratology of any type.
  * Pharmacological agents:

    * Atropine with a concentration \> 0.01%. Participants who have previously used 0.01% atropine are eligible for this study provided they agree not to use 0.01% atropine for at least 30 days before baseline and at any time during the study.
    * Pirenzepine
* Participant born earlier than 30 weeks or weighed \< 1500 g at birth.

  * A verbal report from the participant's parent / legal guardian is sufficient.
* Habitual use of a systemic or topical medication that may alter normal ocular findings / is known to affect a participant's ocular health / physiology either in an adverse or beneficial manner at enrolment and / or during the clinical trial.
* A known allergy to sodium fluorescein, benoxinate, proparacaine, tropicamide, or cyclopentolate.
* Strabismus as determined by cover test at distance (≥ 3 m) or near (40 cm) while wearing distance correction under non-cycloplegic conditions.
* Known ocular or systemic disease, such as but not limited to:

  * Diabetes.
  * Graves' disease.
  * Glaucoma.
  * Uveitis.
  * Scleritis.
  * Auto immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjogrens syndrome, and systemic lupus erythematosus.
* Any ocular, systemic, or neuro-developmental conditions that could influence refractive development, such as but not limited to:

  * Persistent pupillary membrane.
  * Vitreous haemorrhage.
  * Cataract.
  * Central corneal scarring.
  * Eyelid haemangiomas.
  * Marfan's syndrome.
  * Down's syndrome.
  * Ehler's-Danlos syndrome.
  * Stickler's syndrome.
  * Ocular albinism.
  * Retinopathy of prematurity.
* Keratoconus or irregular cornea.
* The investigator may, at their discretion, exclude anyone who they believe may not be able to fulfil the clinical trial requirements or it is believed to be in the participant's best interests.

Where this trial is running

Tianjin, Heping District and 4 other locations

• Tianjin Eye Hospital — Tianjin, Heping District, China (Recruiting)
• Shanghai Fudan University Eye and ENT Hospital — Shanghai, Xuhui District, China (Recruiting)
• Divyajyoti Trust Tejas Eye Hospital — Surat, Gujarat, India (Recruiting)
• LV Prasad Eye Institute — Hyderabad, Telangana, India (Recruiting)
• Pristine Eye Hospitals — Hyderabad, Telangana, India (Not_yet_recruiting)

Study contacts

• Principal investigator: Daniel Tilia, Optom, PhD — nthalmic Pty Ltd
• Study coordinator: Daniel Tilia, MOptom, PhD

Conditions Myopia