Efficacy of Different Interventions for Progressive Myopia After Orthokeratology Lens Wear

Participants were categorized into four distinct groups based on the intervention strategy:1) OK group: Participants continued using Ortho-K lenses without any additional intervention; 2) OKA group: Participants used Ortho-K lenses supplemented with 0.01% atropine eye drops administered nightly in both eyes; 3) OKBC group: At the 12-month interval, participants transitioned to Ortho-K lenses featuring a reduced optical zone, maintaining the same lens brand and other parameters; 4) OKRL group: Participants used Ortho-K lenses in conjunction withe repeated low-level red-light (RLRL) therapy administered twice daily in both eyes. Measurements were systematically recorded at 6 and 12 months following the intervention.(Figure 1. Participants flowchart.) Ortho-K Lenses: This study did not impose restriction the design or brand of Ortho-K lenses. Lens replacement was permissible to satisfy refractive and fitting criteria, provided the brand remained unchanged from that used prior to enrollment. The OKBC group was uniquely permitted to modify the back optical zone diameter parameter of the Ortho-K lenses.

0.01% Atropine Eye Drops: These were supplied by Shenyang Xingqi Eye Medicine Co., Ltd. The prescribed usage involved instilling one drop in each eye 10 minutes before the nightly application of Ortho-K lenses .

Repeated low-level red-light Therapy Device: This device was supplied by Suzhou Xuanjia Photoelectric Technology Co., Ltd. [16]. The prescribed usage protocol involved administering the therapy, twice daily, with each session lasting 3 minutes and a minimum intercal of 4 hours between sessions, conducted 7 days a week.

Inclusion criteria

• The initial fitting age is between 8-12 years, irrespective of gender; 2) The spherical equivalent refraction (SE) of both eyes at the initial fitting falls within the manufacturer's approved range of -6.00D to -0.50D; 3) The best corrected visual acuity of both eyes is ≥1.0 (Snellen); 4) The ability to ensure overnight Ortho-K lens wear for a duration of 8 to 10 hours; 5) No prior history of ocular trauma or surgery; 6) No prior history of acute or chronic ocular inflammation, such as keratoconjunctivitis or abnormal tear film; 7) The ability to meticulously adhere to instructions for lens care and attend regular follow-up examinations; 8) The standard use of other myopia progression interventions, such as 0.01% atropine or red-light therapy as prescribed; 9) Comprehensive follow-up data; 10) At least one eye exhibits an annual axial length elongation of >0.30 mm during the first year of Ortho-K lens wear.

Exclusion criteria

• Axial length elongation less than 0.30 mm in both eyes during the first year of Ortho-K treatment; 2) Incidence of significant complications during the study period, such as recurrent corneal inflammation; 3) Incomplete data or cases lost to follow-up; 4) SE of either eye less than -6.00D, or astigmatism greater than -2.00D; 5) Unstable vision during Ortho-K treatment, characterized by multiple instances of vision below 0.2 (LogMAR); 6) Change in the brand of Ortho-K lens.

This study utilized a retrospective data collection approach. To prevent the influence of non-independent data from both eyes of a single participant on statistical analyses, data from only one eye per subject were included in the final analysis. The selection criterion prioritized data from the right eye; however, if the right eye did not satisfy the primary inclusion criterion of "annual axial elongation >0.30 mm," data from the left eye were used instead. This study was conducted in accordance with the Declaration of Helsinki and received approval from the Ethics Committee of the Tianjin Medical University Eye Hospital. Informed consent was obtained from the guardians of all participating children.