Dry Eye Syndrome Description During Cataract Surgery, With Multimodal Analysis of the Ocular Surface — C-SS0  

Dry Eye Syndrome Clinical Trial

Official title: Dry Eye Syndrome Description During Cataract Surgery, With Multimodal Analysis of the Ocular Surface

Status Completed

Clinical Trial Summary

The main objective is to describe the characteristics of dry eye syndrome before and after surgery at one month of cataract surgery, using a multimodal analysis of the ocular surface.

The secondary objectives are to evaluate:

• Predictive factors of dry eye syndrome during cataract surgery:

• The characteristics of dry eye syndrome

• Implications for the patient's quality of life

Clinical Trial Description

Type of study: Descriptive study, interventional research involving the human person at risk and with minimal constraints (type 2), prospective, with longitudinal cohort follow-up, mono-centric.

Number of centres: 1; The protocol will take place in the ophthalmology department of the Clermont-Ferrand University Hospital.

Study description: The study will follow the normal protocol for cataract surgery. Patients will not have any additional consultation to perform this study. The classic consultation scheme involves a preoperative appointment to set the surgical indication and inform patients about the procedure, the benefits - risks and usual follow-up.. During this consultation, the patient will have to complete a quality of life questionnaire in addition to the standard protocol, and will also have to perform a non-invasive Schirmer test and a non-contact examination of the ocular surface analysis (Lacrydiag from the Quantel laboratory, with CE marking). The patient will be seen again in a traditional post-operative consultation one month after the surgery, the same examinations will be performed.

We will use the pre and postoperative ophthalmological consultation reports, the operative report, as well as a patient questionnaire and surface analysis examination reports to conduct the study.

Main judgment criteria:

Analysis of the ocular surface defined by the study:

• OSDI questionnaire score (Ocular Surface Disease Index)

• Corneal / conjunctival states visible in slit lamp (Oxford score)

• Eyelid analysis by meibography (qualitative analysis of the eyelid glands of Meibomius and calculation of the percentage loss)

• Study of the tear film:

Lipid layer by interferometry (thickness assessment; qualitative and quantitative analysis) Aqueous layer by measuring the height of the lacrimal meniscus (quantitative analysis) Mucinic layer by evaluating the stability of the tear film (Non Invasive Break Up Time)

o Evaluation of tear secretion (Schirmer type I test)

• Eyelid analysis and tear film study will be performed simultaneously by the non-invasive test Lacrydiag.

• Definition and classification of an SSO according to different severity grades.

Secondary Judgement Criteria: Evaluate during cataract surgery:

• Predictive factors of dry eye syndrome during cataract surgery:

• Age

• Gender

• General history / Systemic diseases / Eye diseases o General and topical medication use

• Type of anesthesia used for surgery

• The characteristics of dry eye syndrome

• Incidence of dry eye syndrome before and after surgery in our centre

• Correlation between subjective criteria (OSDI score) and objective criteria (results of evaluation by non-invasive tests)

• Comparison on a sample of patients (without adelphic eye pathology) in after cataract surgery between the two eyes.

• Consequences on the patient's quality of life (translated questionnaire from the Ocular Surface Disease Index from 0 to 48)

• visual symptoms

• activity limitations

• adaptation to the environment

• Post-operative satisfaction ;

Related Conditions & MeSH terms

• Cataract
• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Ocular Surface Disease
• Syndrome

• NCT number: NCT03923244
• Study type: Interventional
• Source: University Hospital, Clermont-Ferrand
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Completion date: March 6, 2020