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Metabo-lipidomics of the Ocular Surface for Cataract Surgery

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05802550
Acronym
CATARACTOMIQUE
Enrollment
100
Registered
2023-04-06
Start date
2023-09-04
Completion date
2025-07-09
Last updated
2026-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-related Cataract

Keywords

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

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.

Interventions

Questionnaire on ocular surface disorders

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

OTHEROxford score

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

OTHERConjunctival collection

Two conjunctival prints: one for metabolomic and one for lipidomic

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

OTHERQuantification of Tyndall and flare

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

Sponsors

University Hospital, Tours
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative ocular surface disease1 months after cataract surgeryMetabo-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.

Secondary

MeasureTime frameDescription
Change in number and semi-quantitative concentrations of ocular surface metabolitesFrom baseline to 1 month after cataract surgeryComparison of ocular surface metabolome using conjunctival impression cytology pre and postoperatively 1 month after cataract surgery
Change in number and semi-quantitative concentrations of ocular surface lipidsFrom baseline to 1 month after cataract surgeryComparison of ocular surface lipidome using conjunctival impression cytology pre and postoperatively 1 month after cataract surgery

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026