Clinical applicability of the WaveFront Phase Imaging Sensor in the Keratoconus Disease

Abstract

Significance: The analysis of the wavefront phase of keratoconus eyes has become increasingly important due to its impact on the assessment of visual quality loss, irrecoverable with conventional optical treatments, and the understanding of morphological changes in corneal structures. Aim: The aim of this work is to quantitatively assess the wavefront phase of keratoconic eyes measured by the novel high-resolution ocular aberrometer t-eyede (based on WaveFront Phase Imaging Sensor). Approach: The measurements with this device were taken on healthy and keratoconic eyes at the Hospital Universitario Fundacion Jimenez Diaz (Madrid, Spain). The wavefront phase recovered is post-processed and displayed in different phase maps, using exclusively the high-pass filter map for this study. From this map, the Root Mean Square, the Peak-to-Valley, and the amplitude value of the predominant obtained from its Fourier Transform are the parameters to distinguish between healthy and keratoconic eyes. Furthermore, the banding pattern observed in most keratoconic eyes is quantitatively analyzed by means of its period and orientation calculated from the Fourier Transform. Results: The Control group was composed of 43 healthy eyes, and the Pathological group presented 43 keratoconic eyes. Regarding the first three parameters used to compare both groups, there were significant statistical differences between them in all parameters, where the values obtained with the keratoconic group were higher than those of the healthy group. Although the values cannot be statistically comparable between stages, they tended to increase according to the severity of the disease. On the other hand, analyzing the banding pattern, the mean value of the period was approximately 50 microns, and most orientations were obliquus, tending to be horizontal rather than vertical. Conclusions: The present study demonstrates that the objective analysis of the high frequencies detected by this wavefront sensor is a potential tool to reliably advise in the keratoconus diagnosis. Furthermore, combining this achievement with the quantitative assessment of the banding pattern would be used to objectively monitor the internal corneal status throughout the disease and its treatment optimization and surgery time.

Competing Interest Statement

CBP, MVO, JMTS, and IRM are employees of Wooptix S.L., JMRR is Chief Executive Officier at Wooptix S.L., and the rest of the authors (SRG, GVR, NAA, and JRM) have no competing interests.

Funding Statement

Wooptix S.L.

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:

Ethics committee/IRB of Hospital Universitario Fundacion Jimenez Diaz 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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