CataractHYPERLAFNCT07875205
Imaging and Spectral Analysis of the Crystalline Lens Using the "HYPERLAF" Slit Lamp
A study testing Non-contact observation of the crystalline lens nucleus in people with Cataract, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Non-contact observation of the crystalline lens nucleus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2026to 30 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients enrolled in or eligible for a social security program
- Age 18 or older
- Patients with cataracts. In cases of bilateral cataracts, both eyes will be photographed and analyzed.
- Patient who has already received an instillation of 0.5% mydriaticum (tropicamide) and 10% neosynephrine (Théa Laboratories, Clermont-Ferrand, France) eye drops to dilate the pupil of the eye to be photographed (or both eyes).
- Signature of the consent form
Who cannot join
- Severe blepharospasm making the examination impossible.
- Poor or absent pupil dilation: patient with an allergy or intolerance to the eye drops used for pupil dilation; refusal of pupil dilation during the eye examination.
- Pregnant or breastfeeding patient
- person under legal guardianship
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU de Saint-Etienne
Saint-Etienne, 42055
Gilles THURET, PHD, (0)4 77 12 77 96 ext. +33, Gilles.Thuret@chu-st-etienne.fr
Gilles THURET, PHD
About this study
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.
- Conditions
- Cataract
- Being tested
- Non-contact observation of the crystalline lens nucleus
- Keywords
- cataract, grading, slit lamp, spectral analysis
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-contact observation of the crystalline lens nucleusDiagnostic test
Non-contact observation of the crystalline lens nucleus with a modified slit lamp combining an imaging system and a spectral measurement.
| Study group | Role | What they receive |
|---|---|---|
| Patients with cataracts | Experimental | 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. Receives: Diagnostic Test: Non-contact observation of the crystalline lens nucleus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: at inclusion, This is a one-day study.
Secondary outcomes (8)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at inclusion, this is a one-day study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study startOct 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot, uncontrolled, single-center study.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875205
- Sponsor's protocol ID
- 26CH176
- Other IDs
- ANSM
- Acronym
- HYPERLAF
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No