Efficacy of Different Interventions for Progressive Myopia After Orthokeratology Lens Wear

NCT07494799 | Not Yet Recruiting FDA Drug FDA Device

• 1 other identifier: 2026RN16
• Study Type: observational
• Target: 3,890
• Locations: 0 countries
• Sites: N/A

Brief Summary

Myopia has emerged as a significant concern impacting the visual health of children and adolescents on a global scale. According to research conducted by Holden BA et al., it is projected that by the year 2050, the worldwide prevalence of myopia and high myopia will experience a substantial increase, affecting approximately 5 billion and 1 billion individuals, respectively, with particularly high prevalence rates observed in East Asia\[1\]. The persistent rise in myopia incidence, coupled with the escalation of complications associated with high myopia, is anticipated to exert complex socio-economic repercussions \[2\]. Consequently, the prevention of myopia onset and the management of axial length elongation have become critically important \[3\]. Orthokeratology (Ortho-K) is a procedure that involves the overnight application of specially designed reverse geometry rigid gas permeable contact lenses to achieve temporary corneal reshaping and reduce myopia during the day\[4,5\]. In children with mild to moderate myopia, Ortho-K has demonstrated visual correction efficacy ranging from 80% to 92%\[6,7\]. Nonetheless, its efficacy in controlling myopia progression may not match its corrective efficacy. The therapeutic effect of Ortho-K in decelerating axial elongation is reported to range from 43% to 63%. Despite the use of Ortho-K, approximately 15% of children continue to exhibit rapid axial elongation exceeding 0.36 mm per year.\[8,9\]. In recent years, adjunctive interventions such as low-concentration atropine eye drops, modification of the back optical zone diameter (BOZD) of orthokeratology (Ortho-K) lenses, and low-level red-light therapy (RLRL) have been proposed to augment the myopia control efficacy of Ortho-K. Zhao et al. \[10\] reported that after one year of treatment with either atropine orthokeratology (AOK) or Ortho-K lenses in children aged 5-14 years, the axial length (AL) increased by 0.14 mm and 0.29 mm, respectively. Another study involving children aged 8-12 years \[11\] demonstrated that after one year of treatment, the AOK group exhibited a 17% reduction in AL growth (0.20 mm vs. 0.24 mm). Research conducted by Xiong et al. \[12\] indicated that for children whose eyes elongated by at least 0.50 mm within one year of Ortho-K wear, the combination of RLRL therapy with Ortho-K significantly reduced axial elongation compared to Ortho-K alone. Additional studies have suggested that decreasing the BOZD can enhance the extent and degree of mid-peripheral corneal steepening, thereby decelerating axial elongation \[13-15\]. Most existing studies primarily compare a single intervention against a control group, thereby lacking direct "head-to-head" comparisons. Traditional meta-analyses are limited to comparing two interventions at a time and often fail to assess multiple treatments concurrently. Consequently, most meta-analyses offer only statistical insights into the efficacy of individual interventions. Clinically, it is common to combine two or more interventions to treat myopia, particularly in cases of rapidly progressive myopia. Previous research has indicated that combined interventions may have additive effects in the prevention and control of myopia; however, these findings require further empirical validation. This study employs a retrospective approach to evaluate the efficacy of various treatment strategies in managing axial elongation in children aged 8-12 years who experience rapid axial progression following Ortho-K lens wear. The objective is to provide a scientific foundation for the development of personalized myopia control plans.

Conditions

Progressive Myopia; Pediatric Myopia; Orthokeratology-related Myopia Progression

Keywords

Repeated low-level red-light therapy; Orthokeratology; Atropine; Small optical zone design

Outcome Measures

Primary Outcomes (2)

• Change in Axial Length from Baseline at 12 Months

  Axial length is measured by IOL-Master 700, and the change value is calculated by comparing with the baseline value before intervention.

  12 Months

• Change in Axial Length from Baseline at 12 Months

  Axial length is measured by IOL-Master 700, and the change value is calculated by comparing with the baseline value before intervention. This is the primary efficacy endpoint to evaluate the myopia control effect of different interventions.

  12 Months

Secondary Outcomes (2)

• Change in Axial Length from Baseline at 6 Months

  6 Months

• Incidence of Adverse Events

  12 Months

Study Arms (4)

OK Lens Continuation Group

Continue wearing original orthokeratology lenses with unchanged parameters, follow-up every 6 months.

Device: OK Lens Continuation Group

OK Lens + 0.01% Atropine Group

Continue OK lenses + 0.01% atropine sulfate eye drops once daily at bedtime.

Drug: OK Lens + 0.01% Atropine Group

OK Lens with Reduced Optical Zone Group

Wear OK lenses with reduced optical zone diameter (adjusted by 0.5mm from original parameters).

Device: OK Lens with Reduced Optical Zone Group

OK Lens + Low-Intensity Red Light Group

Continue OK lenses + low-intensity red light therapy (630nm, 6 minutes daily).

Device: OK Lens + Low-Intensity Red Light Group

Interventions

OK Lens Continuation Group DEVICE

Continue wearing original orthokeratology lenses with unchanged parameters, follow-up every 6 months.

OK Lens Continuation Group

OK Lens + 0.01% Atropine Group DRUG

Continue OK lenses + 0.01% atropine sulfate eye drops once daily at bedtime.

OK Lens + 0.01% Atropine Group

OK Lens with Reduced Optical Zone Group DEVICE

Wear OK lenses with reduced optical zone diameter (adjusted by 0.5mm from original parameters).

OK Lens with Reduced Optical Zone Group

OK Lens + Low-Intensity Red Light Group DEVICE

Continue OK lenses + low-intensity red light therapy (630nm, 6 minutes daily).

OK Lens + Low-Intensity Red Light Group

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children aged 8-12 years with myopia who have worn orthokeratology (OK) lenses for at least 1 year, with axial length elongation \>0.3mm in the past 12 months, indicating progressive myopia despite OK lens wear. Both male and female participants are eligible, with no gender restriction.

You may qualify if:

• \) 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.

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Tianjin Medical University Eye Hospital: lead

MeSH Terms

Conditions

Myopia, Degenerative

Condition Hierarchy (Ancestors)

Myopia; Refractive Errors; Eye Diseases

Central Study Contacts

Rui Hua Professor of Ophthalmology, Chief Physician

CONTACT

(8622) 86428752; 743071296@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Ophthalmology, Chief Physician

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: March 27, 2026
• Study Start: April 1, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share