Metabo-lipidomics of the Ocular Surface for Cataract Surgery

Not Applicable

Recruiting

• Conditions: Age-related Cataract
• Interventions: Other: Ocular Surface Disease Index; Other: Interferometry; Other: Oxford score; Other: Conjunctival collection; Other: Aqueous humor collection; Other: Quantification of Tyndall and flare

• Registration Number: NCT05802550
• Lead Sponsor: University Hospital, Tours

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-13
• Study First Submitted QC: 2023-03-24
• Study First Posted: 2023-04-06
• Study Start: 2023-09-04
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-04
• Last Update Posted: 2023-12-05
• Primary Completion: 2024-07-15
• Study Completion: 2024-07-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Longitudinal cohort study in cataract patients	Aqueous humor collection	Longitudinal, open-label, single-center cohort study in cataract patients.
Longitudinal cohort study in cataract patients	Interferometry	Longitudinal, open-label, single-center cohort study in cataract patients.
Longitudinal cohort study in cataract patients	Ocular Surface Disease Index	Longitudinal, open-label, single-center cohort study in cataract patients.
Longitudinal cohort study in cataract patients	Oxford score	Longitudinal, open-label, single-center cohort study in cataract patients.
Longitudinal cohort study in cataract patients	Conjunctival collection	Longitudinal, open-label, single-center cohort study in cataract patients.
Longitudinal cohort study in cataract patients	Quantification of Tyndall and flare	Longitudinal, open-label, single-center cohort study in cataract patients.

Primary Outcome Measures

Name	Time	Method
Postoperative ocular surface disease	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 Outcome Measures

Name	Time	Method
Change in number and semi-quantitative concentrations of ocular surface metabolites	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
Change in number and semi-quantitative concentrations of ocular surface lipids	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

Trial Locations

Locations (1)

KHANNA; 🇫🇷 Tours, France