Metabo-lipidomics of the Ocular Surface for Cataract Surgery

Age-related Cataract Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05802550
• Other study ID #: DR220231
• Status: Recruiting
• Phase: N/A
• Start date: September 4, 2023
• Est. completion date: July 15, 2024

Study information

• Verified date: December 2023
• Source: University Hospital, Tours
• Contact: RAOUL KANAV KHANNA
• Phone: 02 47 47 27 67
• Email: raoul.khanna[@]univ-tours.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 15, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age-related Cataract
• Cataract

Intervention

Other:
• Ocular Surface Disease Index
Questionnaire on ocular surface disorders
• Interferometry
Non-contact examination measuring NIBUT (non-invasive break-up time), meibography and tear meniscus measurement
• Oxford score
Investigation and quantification of superficial corneal punctate keratitis using the Oxford score
• Conjunctival collection
Two conjunctival prints: one for metabolomic and one for lipidomic
• 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.
• Quantification of Tyndall and flare
Quantification of Tyndall and flare (from 1 to 4 crosses) in anterior chamber

Locations

Country	Name	City	State
France	KHANNA	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 months after cataract surgery
Primary	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.	3 months after cataract surgery
Secondary	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	From baseline to 1 month after cataract surgery
Secondary	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	From baseline to 1 month after cataract surgery