Efficacy of Highly Aspherical Lenslet (HAL) spectacles in slowing myopia progression in children and adolescents: A multi-centre, retrospective, real-world study in India-SOLIDITY study

ABSTRACT

Objective The study aims to evaluate the real-world effectiveness of Highly Aspherical Lenslets spectacle (HAL; Essilor® Stellest®) in slowing myopia progression among Indian children and adolescents aged between 4 and 16 years.

Methods and analysis This was a multicentre retrospective study conducted across 10 leading ophthalmic centers. The study participants comprised children aged between 4 and 16 years who were prescribed HAL spectacles (Essilor® Stellest®). Data were extracted from electronic medical records at three time points: T1: One year prior to intervention; T2: Baseline at HAL spectacle prescription; T3: 6 to 24 months after prescription. The primary endpoint was the myopia progression and axial elongation in the year following prescription, compared with the untreated year and with published meta-regression models. Only data from the right eye were analysed, with the expected physiological progression estimated based on the individual progression trajectory after adjusting for age-related slowing as reported in published meta-regression models.

Results A total of 372 myopic children were included in the study. The annual myopia progression was –0.72 ± 0.47 D/year during the untreated period, reducing to –0.11 ± 0.29 D/year with HAL spectacle wear. The expected progression without treatment was –0.65 D/year, based on trajectory-adjusted modelling, indicating a treatment effect of 0.54 D/years and an estimated 83% slowing in myopia progression compared to expected progression. The expected axial elongation under physiological conditions was 0.29 mm/year, estimated using age-adjusted meta-regression models; with HAL lens wear, axial elongation was 0.11 ± 0.16 mm/year, corresponding to a ∼62% relative slowing of elongation.

Conclusion The present study demonstrates the real-world evidence validating the efficacy of HAL lenses as an effective myopia control intervention in Indian children and adolescents. The retrospective design and limited follow-up period warrant future prospective, long-term studies to validate these findings.

Competing Interest Statement

KS and OP are employees of Essilor Luxottica. MB serves as a consultant and scientific advisor to Essilor Luxottica and has received consultancy fees and/or honoraria for advisory activities. The remaining authors declare no competing interests.

Funding Statement

Yes

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Ethical approval was obtained from the ACE Independent Ethics Committee and subsequently from institutional review boards at all participating centres. Due to the retrospective and anonymised nature of the data, individual informed consent was waived.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

The data supporting the findings of this study are available from the corresponding author upon reasonable request, subject to compliance with applicable privacy and ethical considerations.

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