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Not yet recruitingNCT07494799Updated Apr 1, 2026

Efficacy of Different Interventions for Progressive Myopia After Orthokeratology Lens Wear

An observational study in Progressive Myopia, Pediatric Myopia and Orthokeratology-related Myopia Progression, sponsored by Tianjin Medical University Eye Hospital. Not yet recruiting. Open to participants aged 8 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-04-01.

Sponsored by Tianjin Medical University Eye Hospital · Observational

From the registry’s dates

  • Primary completion was expected by May 2026, 6 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
3,890
Ages
8 Years to 12 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Progressive Myopia
  • Pediatric Myopia
  • Orthokeratology-related Myopia Progression

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Keywords

  • Repeated low-level red-light therapy
  • Orthokeratology
  • Atropine
  • Small optical zone design
03

In context

Myopia, Degenerative

71 studies on the registry are indexed under Myopia, Degenerative; 20 are open to participants now.

This study's planned enrollment of 3,890 is above the median of 230 across 11 observational studies indexed under Myopia, Degenerative.

Browse Myopia, Degenerative studies →

Lead sponsor

Tianjin Medical University Eye Hospital is the lead sponsor of 18 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

1) 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

Exclusion Criteria:

1) 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. was obtained from the guardians of all participating children.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
3,890 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • DeviceOK Lens Continuation Group

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

  • DrugOK Lens + 0.01% Atropine Group

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

  • DeviceOK Lens with Reduced Optical Zone Group

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

  • DeviceOK Lens + Low-Intensity Red Light Group

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 Months

  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. This is the primary efficacy endpoint to evaluate the myopia control effect of different interventions.

    Time frame: 12 Months

Secondary outcomes

  1. Change in Axial Length from Baseline at 6 Months

    Time frame: 6 Months

  2. Incidence of Adverse Events

    Including corneal infection, dry eye, lens intolerance, ocular irritation, and other adverse events related to interventions.

    Time frame: 12 Months

07

Study locations

No study locations are listed for this record.

08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07494799
Lead sponsor
Tianjin Medical University Eye Hospital
Responsible party
Ruihua Wei (Professor of Ophthalmology, Chief Physician, Tianjin Medical University Eye Hospital) — Principal investigator
First posted
Mar 27, 2026
Start date
Apr 1, 2026 (estimated)
Primary completion
May 1, 2026 (estimated)
Completion
Apr 1, 2027 (estimated)
Last update
Apr 1, 2026

Study contacts

Rui Hua Professor of Ophthalmology, Chief Physician
Contact
743071296@qq.com
(8622) 86428752

Oversight

FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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