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Completed

NCT Number: NCT05802550

Metabo-lipidomics of the Ocular Surface for Cataract Surgery

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.

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Key information

Conditions

Age-related Cataract Cataract Eye Diseases Lens Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KHANNA

Tours, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ocular Surface Disease Index

Other

Questionnaire on ocular surface disorders

Interferometry

Other

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

Oxford score

Other

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

Conjunctival collection

Other

Two conjunctival prints: one for metabolomic and one for lipidomic

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.

Quantification of Tyndall and flare

Other

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study title

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

Acronym: CATARACTOMIQUE

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 6, 2023
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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