Background: Visual stress is a reading disorder characterised by perceptual distortions, asthenopia and headache whilst reading, alongside increased sensitivity to repeated striped patterns (‘pattern glare’), in the absence of underlying ocular pathology. Coloured filters including tinted spectacle lenses and coloured overlays/acetates have been reported to ameliorate visual stress symptoms. However, evidence on coloured spectacle lenses efficacy at managing symptoms of visual stress, particularly in adults, is lacking, with two recent systematic reviews advocating the need for large-scale randomised control trials.   Methods: This is a double-masked randomised placebo-controlled trial. University students identified with symptoms of visual stress, through use of a reading symptom questionnaire and mid-spatial frequency pattern glare test, will be recruited. Sample size for power of 90% at 5% significance, accounting for 10% dropout will be 65. Participants will be randomly assigned experimental and control coloured spectacle lenses to wear for six weeks followed by a two week washout period, prior to wear of the alternate lenses for a further six weeks with a two week washout period. Participants will compare both sets of spectacle lenses in a ‘head-to-head’ comparison after the secondary washout period, prior to choosing the preferred lenses for voluntary future wear. Long-term adherence to the preferred lenses will be assessed three months post-comparison. Researchers and participants will be masked to spectacle lenses worn throughout the duration of the trial.  Reading performance will be assessed with both sets of lenses at various time points within the trial. A range of reading tests, reading symptoms and pattern glare evaluation will be used to monitor change in reading performance and visual stress symptoms during the trial.   Discussion: The study will evaluate the hypothesis that coloured spectacle lenses increase reading speed and reduce severity and frequency of reading symptoms in adults with visual stress.    Trial Registration: The trial is registered at clinicaltrials.gov: NCT04318106

The authors have declared no competing interest.

ClinicalTrials.gov ID: NCT04318106

Yes

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

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

The protocol has been approved by the Ulster University, School of Biomedical Sciences Ethical Filter Committee as of 28/10/2022 (Ref: FC-BMS-189). This was confirmed by email communication and written confirmation to the authors. The trial is currently listed on ClinicalTrials.gov (Ref: NCT04318106). Participants will be informed that participation in the trial is voluntary and that they can withdraw their participation at any time. In the unlikely event that an adverse incident occurs, it will be reported to the project’s chief investigator S.J.M. and through Ulster University Research Governance protocols.

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.

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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).

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

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No datasets were generated or analysed during the current study. All relevant data from this study will be made available upon study completion.