CATARACTOMIQUE: Metabo-lipidomics of the Ocular Surface for Cataract Surgery

Sponsor
University Hospital, Tours (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05802550
Collaborator
(none)
100
1
1
15
6.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Ocular Surface Disease Index
  • Other: Interferometry
  • Other: Oxford score
  • Other: Conjunctival collection
  • Other: Aqueous humor collection
  • Other: Quantification of Tyndall and flare
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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
Anticipated Study Start Date :
Apr 15, 2023
Anticipated Primary Completion Date :
Jul 15, 2024
Anticipated Study Completion Date :
Jul 15, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: Longitudinal cohort study in cataract patients

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

Other: Ocular Surface Disease Index
Questionnaire on ocular surface disorders

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

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

Other: Conjunctival collection
Two conjunctival prints: one for metabolomic and one for lipidomic

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

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

Outcome Measures

Primary Outcome Measures

  1. Postoperative ocular surface disease [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 [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

  1. 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

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 KHANNA Tours France

Sponsors and Collaborators

  • University Hospital, Tours

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT05802550
Other Study ID Numbers:
  • DR220231
First Posted:
Apr 6, 2023
Last Update Posted:
Apr 10, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Tours
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 10, 2023