Novel non-invasive physical photobiomodulation can treat congenital colour vision deficiency and enhance color vision recognition ability: a randomized, single blind, controlled clinical trial

Abstract

Background: Color vision deficiency (CVD) is a common congenital ophthalmic disease, and no effective therapeutic measures are currently available for this patient population. This study aimed to explore the efficacy of photobiomodulation (PBM) in CVD patients. Methods: A randomized controlled trial design was applied in this study, whereby 80 patients with red-green CVD were randomly divided into PBM treatment and control groups. Color vision was assessed after 1, 2, and 4 weeks of treatment. Statistical analysis of treatment was carried out using the Kruskal-Wallis test with Dunn's test for multiple comparisons using SPSS and R software. Findings: Compared to the control group, the color vision of CVD patients exhibited a significant improvement in the PBM treatment group for different parameters (Ps<0.05). Interpretation: PBM therapy could significantly improve color vision in patients with congenital CVD, especially in patients with green CVD.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

ChiCTR2200056761

Funding Statement

This study did not receive any funding.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The ethics committee of PLA General Hospital gave ethical approval for this work

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

All data produced in the present study are available upon reasonable request to the authors.

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