Spectacle films utilizing S.T.O.P.® technology for slowing down myopia progression in children: A prospective, masked, controlled, randomized, clinical trial.

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 Declaration of Helsinki. This study will be conducted in 3 stages. Participants will be recruited based on the inclusion and exclusion criteria either from The Infor Myopic Clinic, L V Prasad Eye Institute, Hyderabad or by advertisement in local media (newspaper), or approaching schools for referrals. An informed consent will be obtained from each participant (parent/guardian of participating child) after explaining the nature of the study. Assent will be obtained from the participating children. Detailed ocular and medical history will be elicited followed by comprehensive examination (visual acuity, slit lamp examination, open-field autorefraction, subjective refraction), pupillometry, specialty tests such as binocular vision assessments, axial length measurement, peripheral refraction, optical coherence tomography, corneal topography. All participants will undergo cycloplegic refraction after instillation of Tropicamide 1% eye drops. Eligible and willing participant will be sequentially randomized into either one of the two test groups or control group: Control (Single Vision Spectacles); S.T.O.P.®® Kit 1 (AF+30/AF+30 & AF-30/AF-30); S.T.O.P.® Kit 2 (AF+30/AF+30 & AE-30/AE-30). Each S.T.O.P.® kit comprises two pairs of spectacles and each pair of spectacles of each S.T.O.P.® kit has a different pair of spectacle films, i.e., varying in design and/or orientation, applied to them. The participant will then be called for dispensing visit and then following study visits at 1 month, 4 months and 6 months. Stage 2 will commence at the conclusion of the Stage 1 at 6 months visit, and participants will wear lenses with AF180 bilaterally. Stage 3 will commence when the Stage 1 analysis is complete, and the participant is re-randomized into one of two interventions: Dynamic (Best performer:  S.T.O.P.® Kit 1 or S.T.O.P.® Kit 2) and Static (AF+30/AF+30).  The participant will then be called for study visits at 6 months, 12 months, and 18 months. In each follow-up visits, the required ocular parameters such as visual acuity, slit lamp examination, axial length, peripheral refraction, open field autorefraction, subjective refraction (if change in spectacle power is indicated), pupillometry, optical coherence tomography, corneal topography along with participant’s compliance to the spectacles provided will be assessed to analyze the efficacy of these spectacles in controlling myopia progression.