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

February 10, 2026 updated by: University Hospital, Tours

Metabo-lipidomic Analysis of the Ocular Surface and Aqueous Humor for the Search of Predictive Biomarkers of Ocular Surface Disease After Cataract Surgery: a Prospective Cohort Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Longitudinal cohort study in cataract patients
Longitudinal, open-label, single-center cohort study in cataract patients.
Other: Ocular Surface Disease Index
Questionnaire on ocular surface disorders
Other: Interferometry
Non-contact examination measuring NIBUT (non-invasive break-up time), meibography and tear meniscus measurement
Other: Oxford score
Investigation and quantification of superficial corneal punctate keratitis using the Oxford score
Other: Conjunctival collection
Two conjunctival prints: one for metabolomic and one for lipidomic
Other: Aqueous humor collection
Collection of 0.1 mL of aqueous humor immediately after making the accessory corneal incision at the beginning of the cataract surgery.
Other: Quantification of Tyndall and flare
Quantification of Tyndall and flare (from 1 to 4 crosses) in anterior chamber

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative ocular surface disease
Time Frame: 1 months after cataract surgery
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
Time Frame: 3 months after cataract surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in number and semi-quantitative concentrations of ocular surface metabolites
Time Frame: From baseline to 1 month after cataract surgery
Comparison of ocular surface metabolome using conjunctival impression cytology pre and postoperatively 1 month after cataract surgery
From baseline to 1 month after cataract surgery
Change in number and semi-quantitative concentrations of ocular surface lipids
Time Frame: From baseline to 1 month after cataract surgery
Comparison of ocular surface lipidome using conjunctival impression cytology pre and postoperatively 1 month after cataract surgery
From baseline to 1 month after cataract surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2023

Primary Completion (Actual)

July 9, 2025

Study Completion (Actual)

July 9, 2025

Study Registration Dates

First Submitted

March 13, 2023

First Submitted That Met QC Criteria

March 24, 2023

First Posted (Actual)

April 6, 2023

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DR220231

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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