Clinical trial NCT05802550: Metabo-lipidomics of the Ocular Surface for Cataract Surgery
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Age-related Cataract
Keywords: Ocular surface
Cataract
Conjunctival impression cytology
Aqueous humor
Metabolomic
Lipidomic
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Postoperative ocular surface disease
timeFrame: 1 months after cataract surgery
measure: Postoperative ocular surface disease
timeFrame: 3 months after cataract surgery
Secondary outcomes:
measure: Change in number and semi-quantitative concentrations of ocular surface metabolites
timeFrame: From baseline to 1 month after cataract surgery
measure: Change in number and semi-quantitative concentrations of ocular surface lipids
timeFrame: From baseline to 1 month after cataract surgery
Other outcomes:
Locations:
city: Tours
country: France
facility: KHANNA
Study officials:
References: