Metabo-lipidomics of the Ocular Surface for Cataract Surgery (CATARACTOMIQUE)

Regional University Hospital Center (CHRU)

Status: Enrolling

Conditions: Age-related Cataract

Treatments: Other: Conjunctival collection; Other: Aqueous humor collection; Other: Oxford score; Other: Interferometry; Other: Ocular Surface Disease Index; Other: Quantification of Tyndall and flare

Study type: Interventional

Funder types: Other

Identifiers

NCT05802550

DR220231

Details and patient eligibility

About

Cataract is the world's leading cause of blindness, the treatment of which, exclusively surgical, offers excellent results in terms of visual recovery. It represents the most frequently performed surgery in France with more than 800,000 procedures each year. However, some patients develop postoperative ocular surface disease that can affect final visual acuity and quality of life. For example, dry eye disease, very common in the elderly, can be worsened by cataract surgery.

The identification of ocular surface biomarkers predictive of the postoperative risk of ocular surface disease carries the promise of better personalized perioperative care.

Conjunctival impression cytology represents a rapid, minimally invasive method of collecting conjunctival cells, which has proven its usefulness in the evaluation of diseases of the ocular surface. The aqueous humor is directly accessible at the beginning of the surgery.

An approach combining ultra-high performance liquid chromatography coupled with high-resolution mass spectrometry on the cells of the ocular surface and on the aqueous humor could improve our understanding of the physiopathology of ocular surface disease following cataract surgery.

This study will aim to 1) search for prognostic biomarkers of ocular surface disease after cataract surgery using a metabo-lipidomic approach 2) improve our understanding of the pathophysiological mechanisms involved.

Enrollment: 100 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with cortico-nuclear and/or subcapsular cataract
• Age > or = 50 years
• Patient affiliated to a social security system
• Patient agreeing to participate in the study who provided his/her free and informed written consent

Exclusion criteria

• History of ocular surgery or trauma (≤ 3 months)
• Other types of cataract excepted age-related or diabetic cataract
• Any eye drops or treatments that may interfere with the ocular surface
• Lens wearer
• Any general pathology with a known impact on the ocular surface (auto-immune disease, allergy)
• Proven allergy to povidone-iodine or to a component of the postoperative treatment
• Patient under legal protection (safeguard of justice, curatorship and guardianship), or in a situation of deprivation of freedom
• Patient unable to understand the nature and objectives of the study

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Longitudinal cohort study in cataract patients

Other group

Description:

Longitudinal, open-label, single-center cohort study in cataract patients.

Treatment:

Other: Conjunctival collection

Other: Oxford score

Other: Interferometry

Other: Aqueous humor collection

Other: Quantification of Tyndall and flare

Other: Ocular Surface Disease Index