Imaging and Spectral Analysis of the Crystalline Lens Using the "HYPERLAF" Slit Lamp

Condition(s) studied

Investigational drug(s) / intervention(s)

Non-contact observation of the crystalline lens nucleus: Non-contact observation of the crystalline lens nucleus with a modified slit lamp combining an imaging system and a spectral measurement.

Study summary

Cataract is the leading cause of reversible blindness and the first surgery worldwide. It corresponds to the crystalline lens opacification. Nevertheless, its grading remains mostly subjective and the Lens Opacities Classification System dating back 1993, is not used in daily practice and has not been revisited since. The HYPERLAF device developed by the start-up HYPEREYE is a modified slit lamp which combines imaging and spectral analysis, providing two quantitative objective scores: OPAK (opacity) and COLOR (spectral analysis). It is a non-CE marked prototype with non-invasive imaging methods.

Eligibility

Primary outcome measure(s)

• Reproducibility of COLOR score measurement. — at inclusion, This is a one-day study.
  To assess the reproducibility of the COLOR score measurement, we will perform three consecutive measurements for each lens in each subject. In practice, the measurement procedure will be repeated from the beginning: for each measurement, the patient will sit on the LAF, the observer will focus the light on the lens, take the measurement, and then move on to the other eye. At the end, the patient will step back. Reproducibility will be quantified using the intraclass correlation coefficient (ICC).

Trial sites (1)

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