NCT05773209

Brief Summary

The choroidal thickness was found to be thinner in diabetic eyes without retinopathy compared to healthy eyes, thus choroidal thickness might be an important parameter for the development of diabetic retinopathy in diabetic eyes without retinopathy. Repeated low-level red-light (RLRL) therapy is an emerging innovative and non-invasive treatment for a variety of eye diseases. Notably, RLRL was found to be effective in thickening choroidal thickness in a 1-year randomized controlled trial, indicating its potential in modulating blood flow in the fundus. This study aims to answer whether RLRL therapy can thicken choroidal thickness in adults with diabetes mellitus or diabetic retinopathy.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable diabetes-mellitus-type-2

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

March 6, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 17, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

April 30, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

April 18, 2023

Status Verified

March 1, 2023

Enrollment Period

6 months

First QC Date

March 6, 2023

Last Update Submit

April 14, 2023

Conditions

Diabetes Mellitus, Type 2Diabetic Retinopathy

Keywords

Repeated low-level red-light (RLRL) therapyChoroidal thickness

Outcome Measures

Primary Outcomes (1)

  • Changes in subfoveal choroidal thickness

    Changes in subfoveal choroidal thickness after 1-month RLRL treatment, which is measured by optical coherence tomography.

    1 month

Secondary Outcomes (3)

  • Changes in choroidal vascularity index

    1 month

  • Changes in OCTA-derived parameters of the choroid and retina

    1 month

  • Changes in DR grading

    1 month

Study Arms (2)

RLRL of 100% intensity

EXPERIMENTAL

Participants will be treated with RLRL treatment (100% intensity) twice per day with an interval of at least 4 hours, each treatment last 3 minutes. Cross over arms after one month of use and one month of washout period.

Device: RLRL device

RLRL of 5% intensity

SHAM COMPARATOR

Participants will be treated with the sham device (5% intensity) twice per day with an interval of at least 4 hours, each treatment last 3 minutes. Cross over arms after one month of use and one month of washout period.

Device: RLRL device

Interventions

RLRL deviceDEVICE

Crossover device (RLRL of 5% 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 5% intensity

Eligibility Criteria

Age35 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 35-55 years
  • Diagnosis of type 2 diabetes mellitus
  • No DR or only mild non-proliferative DR (NPDR) assessed by baseline clinical ocular signs and 7-field fundus color photography

You may not qualify if:

  • Spherical equivalent (SE) ≤ -6.0 diopter or axial length ≥26 mm
  • Patients with complications such as DME and retinal detachment
  • History of ocular surgical operations
  • Severe systemic diseases
  • Those who could not cooperate with the examination for any reason
  • Cognitive impairment or mental illness
  • Patients with other ocular diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes Complications

Study Officials

  • Xiangbin Kong, PhD

    The Second People's Hospital of Foshan, Guangdong Province,China

    STUDY CHAIR

Central Study Contacts

Xiangbin Kong, PhD

CONTACT

+86075788032111xiangbin_kong@sina.com

Cong Li, MD

CONTACT

leoleelc@163.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

March 6, 2023

First Posted

March 17, 2023

Study Start

April 30, 2023

Primary Completion

October 30, 2023

Study Completion

December 30, 2023

Last Updated

April 18, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Not Provided