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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

There are two parts to this trial. First, to compare the rate of myopia progression of spectacle films using Spatio Temporal Optic Phase (S.T.O.P.®) technology that provide a dynamic optical cue against single vision spectacle lenses. Second, to compare the rate of myopia progression of spectacle films using S.T.O.P.® technology that provide a dynamic optical cue against spectacle films using S.T.O.P.® technology that provide a static optical cue. A dynamic optical cue is one that changes, and a static optical cue is one that does not change.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 14
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Shanghai Fudan University Eye and ENT Hospital
RECRUITING
Shanghai
Tianjin Eye Hospital
RECRUITING
Tianjin
India
LV Prasad Eye Institute
RECRUITING
Hyderabad
Pristine Eye Hospitals
NOT_YET_RECRUITING
Hyderabad
Divyajyoti Trust Tejas Eye Hospital
RECRUITING
Surat
Contact Information
Primary
Daniel Tilia, MOptom, PhD
d.tilia@nthalmic.com
+6129037700
Time Frame
Start Date: 2023-12-22
Estimated Completion Date: 2026-09
Participants
Target number of participants: 210
Treatments
Active_comparator: Assigned Intervention 1
Single vision spectacle lens
Experimental: Assigned Intervention 2
Single vision spectacle lens + S.T.O.P.® Kit 1
Experimental: Assigned Intervention 3
Single vision spectacle lens + S.T.O.P.® Kit 2
Active_comparator: Assigned Intervention 4
Static optical signal: single vision spectacle lens + S.T.O.P.® spectacle film
Experimental: Assigned Intervention 5
Dynamic optical signal: single vision spectacle lens + S.T.O.P.® Kit 1 or 2
Related Therapeutic Areas
Sponsors
Collaborators: Zhong Jing Wei Shi (Suzhou) Optical Technology Ltd.
Leads: nthalmic Pty Ltd

This content was sourced from clinicaltrials.gov

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