NCT07186088

Brief Summary

To explore the effectiveness and safety of repeated exposure to repeated low-intensity red light

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Sep 2025Jun 2026

First Submitted

Initial submission to the registry

August 31, 2025

Completed
20 days until next milestone

Study Start

First participant enrolled

September 20, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2026

Expected
Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

August 31, 2025

Last Update Submit

September 15, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Axial length

    From enrollment to the end of treatment up to 7 months

Secondary Outcomes (2)

  • Spherical equivalent

    From enrollment to the end of treatment up to 7 months

  • Choroidal thickness

    From enrollment to the end of treatment up to 7 months

Study Arms (2)

The Laser Group

EXPERIMENTAL

Use Eyerising (RS-200-2A), 1 time,2 times or 3 times a day

Device: Eyerising RS-200-2A

The LED Group

EXPERIMENTAL

Use Airdoc (Sky-n1201), 2 times a day

Device: Airdoc Sky-n1201

Interventions

Eyerising RS-200-2A,1 time,2 times, 3 times a day

The Laser Group

Eyerising RS-200-2A,2 times a day

The LED Group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years old, gender not limited; Obtained informed consent.

You may not qualify if:

  • Obvious strabismus and amblyopia
  • With congenital eye disease, such as congenital cataract, congenital retinal disease
  • Secondary myopia (such as premature retinopathy or other eye diseases in infants and children caused secondary myopia), or myopia combined with systemic syndrome (such as Marfan syndrome)
  • Had internal eye surgery (such as cataract extraction, intraocular lens implantation, anti-glaucoma surgery, etc.)
  • Refractive medium opacity (such as corneal disease, crystal opacity, etc.)
  • Bnormal intraocular pressure and clinical significance (IOP \<10 mmHg or IOP\>21mmHg or binocular IOP difference ≥5mmHg)
  • Fundus chorioretinopathy (except for high myopia fundus degenerative changes) or other intraocular diseases
  • Optic nerve damage or congenital optic nerve dysfunction
  • Can not be regularly checked
  • The adjustment range is less than 8D or obvious near difficulties

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Eye Hospital

Tianjin, Tianjin Municipality, 120120, China

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Ruihua Wei

    Tianjin Medical University Eye Hospital, Tianjin, Tianjin 120120 Recruiting

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 31, 2025

First Posted

September 22, 2025

Study Start

September 20, 2025

Primary Completion

March 20, 2026

Study Completion (Estimated)

June 20, 2026

Last Updated

September 22, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations