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

NCT07875205 | Not Yet Recruiting

• 2 other identifiers: 26CH176ANSM
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cataract

Keywords

cataract; grading; slit lamp; spectral analysis

Outcome Measures

Primary Outcomes (1)

• 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).

  at inclusion, This is a one-day study.

Secondary Outcomes (8)

• Reproducibility of OPAK score

  at inclusion, This is a one-day study.

• Distribution of the COLOR score in the study population

  at inclusion, This is a one-day study.

• Distribution of the OPAK score in the study population

  at inclusion, this is a one-day study

• Association between the COLOR score and LOCS III components

  at inclusion, This is a one-day study.

• Association between the OPAK score and LOCS III components

  at inclusion, this is a one-day study

Study Arms (1)

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.

Diagnostic Test: Non-contact observation of the crystalline lens nucleus

Interventions

Non-contact observation of the crystalline lens nucleus DIAGNOSTIC_TEST

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

Patients with cataracts

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Central Study Contacts

Gilles THURET, PHD

CONTACT

(0)4 77 12 77 96; Gilles.Thuret@chu-st-etienne.fr

Clara PFENNINGER

CONTACT

(0)4 77 12 02 87; clara.pfenninger@chu-st-etienne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot, uncontrolled, single-center study.

Study Record Dates

• First Submitted: October 1, 2026
• First Posted: October 15, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: October 15, 2026

Record last verified: 2026-10

Locations

FR (1)