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

Primary Purpose

Age-related Cataract

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ocular Surface Disease Index
Interferometry
Oxford score
Conjunctival collection
Aqueous humor collection
Quantification of Tyndall and flare
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Age-related Cataract focused on measuring Ocular surface, Cataract, Conjunctival impression cytology, Aqueous humor, Metabolomic, Lipidomic

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • KHANNA

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Longitudinal cohort study in cataract patients

Arm Description

Longitudinal, open-label, single-center cohort study in cataract patients.

Outcomes

Primary Outcome Measures

Postoperative ocular surface disease
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.
Postoperative ocular surface disease
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

Change in number and semi-quantitative concentrations of ocular surface metabolites
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
Comparison of ocular surface lipidome using conjunctival impression cytology pre and postoperatively 1 month after cataract surgery

Full Information

First Posted
March 13, 2023
Last Updated
May 9, 2023
Sponsor
University Hospital, Tours
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1. Study Identification

Unique Protocol Identification Number
NCT05802550
Brief Title
Metabo-lipidomics of the Ocular Surface for Cataract Surgery
Acronym
CATARACTOMIQUE
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 4, 2023 (Anticipated)
Primary Completion Date
July 15, 2024 (Anticipated)
Study Completion Date
July 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Cataract
Keywords
Ocular surface, Cataract, Conjunctival impression cytology, Aqueous humor, Metabolomic, Lipidomic

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Longitudinal cohort study in cataract patients
Arm Type
Other
Arm Description
Longitudinal, open-label, single-center cohort study in cataract patients.
Intervention Type
Other
Intervention Name(s)
Ocular Surface Disease Index
Intervention Description
Questionnaire on ocular surface disorders
Intervention Type
Other
Intervention Name(s)
Interferometry
Intervention Description
Non-contact examination measuring NIBUT (non-invasive break-up time), meibography and tear meniscus measurement
Intervention Type
Other
Intervention Name(s)
Oxford score
Intervention Description
Investigation and quantification of superficial corneal punctate keratitis using the Oxford score
Intervention Type
Other
Intervention Name(s)
Conjunctival collection
Intervention Description
Two conjunctival prints: one for metabolomic and one for lipidomic
Intervention Type
Other
Intervention Name(s)
Aqueous humor collection
Intervention Description
Collection of 0.1 mL of aqueous humor immediately after making the accessory corneal incision at the beginning of the cataract surgery.
Intervention Type
Other
Intervention Name(s)
Quantification of Tyndall and flare
Intervention Description
Quantification of Tyndall and flare (from 1 to 4 crosses) in anterior chamber
Primary Outcome Measure Information:
Title
Postoperative ocular surface disease
Description
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.
Time Frame
1 months after cataract surgery
Title
Postoperative ocular surface disease
Description
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.
Time Frame
3 months after cataract surgery
Secondary Outcome Measure Information:
Title
Change in number and semi-quantitative concentrations of ocular surface metabolites
Description
Comparison of ocular surface metabolome using conjunctival impression cytology pre and postoperatively 1 month after cataract surgery
Time Frame
From baseline to 1 month after cataract surgery
Title
Change in number and semi-quantitative concentrations of ocular surface lipids
Description
Comparison of ocular surface lipidome using conjunctival impression cytology pre and postoperatively 1 month after cataract surgery
Time Frame
From baseline to 1 month after cataract surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
RAOUL KANAV KHANNA
Phone
02 47 47 27 67
Email
raoul.khanna@univ-tours.fr
Facility Information:
Facility Name
KHANNA
City
Tours
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RAOUL KANNAV KHANNA, MD
Phone
02 47 47 27 67
Email
raoul.khanna@univ-tours.fr
First Name & Middle Initial & Last Name & Degree
RAOUL KANNAV KHANNA, MD
First Name & Middle Initial & Last Name & Degree
PIERRE-JEAN PISELLA, MD, PhD
First Name & Middle Initial & Last Name & Degree
HELENE BLASCO, PharmD, PhD
First Name & Middle Initial & Last Name & Degree
PATRICK EMOND, PharmD, PhD
First Name & Middle Initial & Last Name & Degree
SOPHIE CATANESE, MD
First Name & Middle Initial & Last Name & Degree
ANTOINE LEFEVRE, MEng
First Name & Middle Initial & Last Name & Degree
NATTIE LECOLIER, Msc

12. IPD Sharing Statement

Plan to Share IPD
No

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Metabo-lipidomics of the Ocular Surface for Cataract Surgery

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