An interventional study of Non-contact observation of the crystalline lens nucleus in Cataract, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Other
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.
1,726 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's planned enrollment of 50 is below the median of 80 across 1,171 interventional studies indexed under Cataract.
Browse Cataract studies →Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 597 studies on the registry; 127 are open to participants now.
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Exclusion Criteria :
Patients will be recruited from the ophthalmology clinic at Saint-Étienne University Hospital. After a clinical diagnosis of cataracts using a slit lamp, patients will be invited to participate in the clinical trial.
Diagnostic Test: 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.
Reproducibility of COLOR score measurement.
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).
Time frame: at inclusion, This is a one-day study.
Reproducibility of OPAK score
To assess the reproducibility of the OPAK 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).
Time frame: at inclusion, This is a one-day study.
Distribution of the COLOR score in the study population
The COLOR score values measured in the study population will be described using appropriate descriptive statistics, including distribution, variability, and minimum and maximum values.
Time frame: at inclusion, This is a one-day study.
Distribution of the OPAK score in the study population
The OPAK score values measured in the study population will be described using appropriate descriptive statistics, including distribution, variability, and minimum and maximum values.
Time frame: at inclusion, this is a one-day study
Association between the COLOR score and LOCS III components
The association between the COLOR score and the individual components of the LOCS III (Lens Opacities Classification System III) score will be analyzed using appropriate statistical methods. LOCS III components will be assessed from digital lens photographs obtained using the LAF as part of routine care in the Ophthalmology Department of Saint-Etienne University Hospital.
Time frame: at inclusion, This is a one-day study.
Association between the OPAK score and LOCS III components
The association between the OPAK score and the individual components of the LOCS III score will be analyzed using appropriate statistical methods. LOCS III components will be assessed from digital lens photographs obtained using the LAF as part of routine care in the Ophthalmology Department of Saint-Etienne University Hospital.
Time frame: at inclusion, this is a one-day study
Proportion of usable device measurements
The feasibility of device measurements will be assessed by calculating the proportion of attempted measurements that yield usable results. The numerator will be the number of usable measurements and the denominator will be the total number of attempted measurements.
Time frame: At inclusion, This is a one-day study.
Frequency of technical difficulties during device measurements
Technical difficulties encountered during device use will be recorded, including difficulties with device alignment and measurement acquisition. The number and nature of these difficulties will be described.
Time frame: at inclusion, this is a one-day study
Duration of the device examination
The time required to perform the device examination will be recorded in minutes for each subject. The examination duration will be summarized using appropriate descriptive statistics.
Time frame: at inclusion, this is a one-day study
Start is estimated for Oct 2026; primary completion for Dec 2026, 2 months later.
Of 316 non-industry interventional studies with no phase under Cataract, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 2 months is below that.
Counting every sponsor, half of 501 studies reached it within 17 months; a quarter within 9 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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