NCT05747742

Brief Summary

The purpose of this clinical trial is to evaluate the effect of different intensities of repeated low-level red-light (RLRL) therapy on the choroidal and retinal blood flow among adults.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 28, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

March 3, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2023

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

3 months

First QC Date

February 17, 2023

Last Update Submit

March 21, 2023

Conditions

ChoroidRetina

Keywords

repeated low-level red light therapychoroidretinaoptical coherence tomographyoptical coherence tomography angiography

Outcome Measures

Primary Outcomes (1)

  • Changes of macular choroidal thickness.

    Changes in the macular choroidal thickness are characterized as the difference following 1 month with RLRL therapy relative to the baseline which is measured by optical coherence tomography.

    1 month

Secondary Outcomes (3)

  • Changes in OCTA-derived parameters of choriocapillaris.

    1 month

  • Changes in OCTA-derived parameters of retina.

    1 month

  • Incidence of treatment-emergent adverse events

    1 month

Study Arms (2)

RLRL of 50% intensity

EXPERIMENTAL

Participants will be treated with RLRL (50% intensity) twice per weekday with an interval of at least 4 hours, each treatment last 3 minutes. Single-vision spectacles with power for correcting distance refraction will also be used if necessary. Cross over arms after one month of use and one month of washout period.

Device: RLRL device

RLRL of 100% intensity

ACTIVE COMPARATOR

Participants will be treated with RLRL (100% intensity) twice per weekday with an interval of at least 4 hours, each treatment last 3 minutes. Single-vision spectacles with power for correcting distance refraction will also be used if necessary. Cross over arms after one month of use and one month of washout period.

Device: RLRL device

Interventions

RLRL deviceDEVICE

Crossover device (RLRL of 50% or 100% intensity - alternate to first group). Cross over arms after one month of use and one month of washout period.

RLRL of 100% intensityRLRL of 50% intensity

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18-40 years at enrolment.
  • Healthy adults with best corrected visual acuity equal to or better than 1.0 in both eyes.
  • No other ocular condition except for myopia.
  • Provision of consent and able to participate in all required activities of the study.

You may not qualify if:

  • Secondary myopia, such as a history of retinopathy of prematurity or neonatal problems, or syndromic myopia with a known genetic disease or connective tissue disorders, such as Stickler or Marfan syndrome.
  • Strabismus and vision abnormalities in either eye.
  • Refractive media opacity: corneal opacities, cataracts, or implanted intraocular lens, etc.
  • Ocular abnormalities that affect retinal function: macular degeneration, diabetic retinopathy, retinal detachment, glaucoma, or ocular hypertension, endophthalmitis, uveitis, optic neuropathy, etc.
  • Previous history of refractive surgery, intraocular surgery, laser therapy, and intravitreal injection, etc.
  • Systemic abnormalities: diabetes, hypertension, etc.
  • Drugs therapies with toxicity effects on the retina: hydroxychloroquine, etc.
  • Other contraindications, including but not limited to ocular or other systemic abnormalities, that the physician may consider inappropriate for enrolment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second People's Hospital of Foshan

Foshan, Guangdong, 528000, China

RECRUITING

Central Study Contacts

Xiangbin Kong, MD. PhD

CONTACT

+86075788032111hxgcrco@shsyf.com

Shiran Zhang, MD

CONTACT

shawn_zhangsr@hotmail.com

Study Design

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

Study Record Dates

First Submitted

February 17, 2023

First Posted

February 28, 2023

Study Start

March 3, 2023

Primary Completion

June 1, 2023

Study Completion

June 27, 2023

Last Updated

March 23, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)