Progressive MyopiaNCT07494799
Efficacy of Different Interventions for Progressive Myopia After Orthokeratology Lens Wear
An observational study of Progressive Myopia and Pediatric Myopia, run by Tianjin Medical University Eye Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Progressive Myopia, Pediatric Myopia, Orthokeratology-related Myopia Progression
- What is being tested?
- OK Lens Continuation Group, OK Lens + 0.01% Atropine Group and OK Lens with Reduced Optical Zone Group
- Type of treatment
- Medical device
- How many people
- 3,890 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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. Informed consent was obtained from the guardians of all participating children.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Study on the Efficacy of Different Interventions for Progressive Myopia in Children After Orthokeratology Lens Wear
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].
Read more
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.
- Being tested
- OK Lens Continuation Group, OK Lens + 0.01% Atropine Group, OK Lens with Reduced Optical Zone Group, OK Lens + Low-Intensity Red Light Group
- Keywords
- Repeated low-level red-light therapy, Orthokeratology, Atropine, Small optical zone design
- Medical subject headings
- Myopia, Degenerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OK Lens Continuation GroupDevice
Continue wearing original orthokeratology lenses with unchanged parameters, follow-up every 6 months.
OK Lens + 0.01% Atropine GroupDrug
Continue OK lenses + 0.01% atropine sulfate eye drops once daily at bedtime.
OK Lens with Reduced Optical Zone GroupDevice
Wear OK lenses with reduced optical zone diameter (adjusted by 0.5mm from original parameters).
OK Lens + Low-Intensity Red Light GroupDevice
Continue OK lenses + low-intensity red light therapy (630nm, 6 minutes daily).
| Study group | Role | What they receive |
|---|---|---|
| OK Lens Continuation Group | Continue wearing original orthokeratology lenses with unchanged parameters, follow-up every 6 months. Receives: Device: OK Lens Continuation Group | |
| OK Lens + 0.01% Atropine Group | Continue OK lenses + 0.01% atropine sulfate eye drops once daily at bedtime. Receives: 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). Receives: 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). Receives: Device: OK Lens + Low-Intensity Red Light Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 Months
Secondary outcomes (2)
Change in Axial Length from Baseline at 6 Months
Measured: 6 Months
Incidence of Adverse Events
Including corneal infection, dry eye, lens intolerance, ocular irritation, and other adverse events related to interventions.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 3,890 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruihua Wei, Tianjin Medical University Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07494799
- Sponsor's protocol ID
- 2026RN16
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on the Efficacy of Different Interventions for Progressive Myopia in Children After Orthokeratology Lens Wear
- ClinicalTrials.gov ID
- NCT07494799
- Acronym / sponsor ID
- 2026RN16
- Keywords
- Repeated low-level red-light therapy, Orthokeratology, Atropine, Small optical zone design
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,890 participants (estimated)
- Lead sponsor
- Tianjin Medical University Eye HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| OK Lens Continuation Group | – | Device: OK Lens Continuation GroupContinue wearing original orthokeratology lenses with unchanged parameters, follow-up every 6 months. |
| OK Lens + 0.01% Atropine Group | – | Drug: OK Lens + 0.01% Atropine GroupContinue OK lenses + 0.01% atropine sulfate eye drops once daily at bedtime. |
| OK Lens with Reduced Optical Zone Group | – | Device: OK Lens with Reduced Optical Zone GroupWear OK lenses with reduced optical zone diameter (adjusted by 0.5mm from original parameters). |
| OK Lens + Low-Intensity Red Light Group | – | Device: OK Lens + Low-Intensity Red Light GroupContinue OK lenses + low-intensity red light therapy (630nm, 6 minutes daily). |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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. Informed consent was obtained from the guardians of all participating children.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OK Lens Continuation GroupContinue wearing original orthokeratology lenses with unchanged parameters, follow-up every 6 months. | Device | OK Lens Continuation Group |
| OK Lens + 0.01% Atropine GroupContinue 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 GroupWear 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 GroupContinue OK lenses + low-intensity red light therapy (630nm, 6 minutes daily). | Device | OK Lens + Low-Intensity Red Light Group |
Primary outcome
Change in Axial Length from Baseline at 12 Months
Time frame: 12 Months
Axial length is measured by IOL-Master 700, and the change value is calculated by comparing with the baseline value before intervention.
Change in Axial Length from Baseline at 12 Months
Time frame: 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.
2 secondary outcomes
Change in Axial Length from Baseline at 6 Months
Time frame: 6 Months
Incidence of Adverse Events
Time frame: 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Progressive Myopia and Pediatric Myopia, run by Tianjin Medical University Eye Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rui Hua Professor of Ophthalmology, Chief Physician ((8622) 86428752, 743071296@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Axial Length from Baseline at 12 Months (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.