Metabo-lipidomics of the Ocular Surface for Cataract Surgery

NCT05802550 | Completed

• 1 other identifier: DR220231
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Age-related Cataract

Keywords

Ocular surface; Cataract; Conjunctival impression cytology; Aqueous humor; Metabolomic; Lipidomic

Outcome Measures

Primary Outcomes (2)

• Postoperative ocular surface disease

  Metabo-lipidomic analysis of intracellular content of the ocular surface preoperatively and aqueous humor intraoperatively to predict occurrence of ocular surface disease 1 month following cataract surgery.

  1 months after cataract surgery

• Postoperative ocular surface disease

  Metabo-lipidomic analysis of intracellular content of the ocular surface preoperatively and aqueous humor intraoperatively to predict occurrence of ocular surface disease 3 months following cataract surgery.

  3 months after cataract surgery

Secondary Outcomes (2)

• Change in number and semi-quantitative concentrations of ocular surface metabolites

  From baseline to 1 month after cataract surgery

• Change in number and semi-quantitative concentrations of ocular surface lipids

  From baseline to 1 month after cataract surgery

Study Arms (1)

Longitudinal cohort study in cataract patients

OTHER

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

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

Interventions

Interferometry OTHER

Non-contact examination measuring NIBUT (non-invasive break-up time), meibography and tear meniscus measurement

Longitudinal cohort study in cataract patients

Oxford score OTHER

Investigation and quantification of superficial corneal punctate keratitis using the Oxford score

Longitudinal cohort study in cataract patients

Conjunctival collection OTHER

Two conjunctival prints: one for metabolomic and one for lipidomic

Longitudinal cohort study in cataract patients

Aqueous humor collection OTHER

Collection of 0.1 mL of aqueous humor immediately after making the accessory corneal incision at the beginning of the cataract surgery.

Longitudinal cohort study in cataract patients

Quantification of Tyndall and flare OTHER

Quantification of Tyndall and flare (from 1 to 4 crosses) in anterior chamber

Longitudinal cohort study in cataract patients

Ocular Surface Disease Index OTHER

Questionnaire on ocular surface disorders

Longitudinal cohort study in cataract patients

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

KHANNA

Tours, France

Location

MeSH Terms

Conditions

Cataract

Interventions

Interferometry

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

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

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: April 6, 2023
• Study Start: September 4, 2023
• Primary Completion: July 9, 2025
• Study Completion: July 9, 2025
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)