Clinical trial NCT03923244: Dry Eye Syndrome Description During Cataract Surgery, With Multimodal Analysis of the Ocular Surface
Official title: Dry Eye Syndrome Description During Cataract Surgery, With Multimodal Analysis of the Ocular Surface
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndrome
Ocular Surface Disease
Keywords: Dry Eye Syndrome
tear film analysis
ocular surface
cataract surgery
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2019-04-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Descriptive study, interventional research involving the human person at risk and with minimal constraints (type 2), prospective, with longitudinal cohort follow-up, mono-centric
Primary purpose: DIAGNOSTIC

Brief 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

Detailed 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

Eligibility criteria: Inclusion Criteria:

* Adult patients (≥ 18 years old)
* consultants to benefit from a scheduled cataract operation at Clermont Ferrand University Hospital
* affiliation to a social security scheme
* ability to give informed consent to participate in the study.

Exclusion Criteria:

* - Patient without cataract surgery
* Congenital cataract
* Refusal to participate in the study
* Inability to answer the questionnaire (cognitive impairment, comprehension difficulties...)
* Eyelid abnormalities that may cause palpebral unocclusion
* Patient under judicial protection (guardianship, curatorship, measure to safeguard justice) or deprived of liberty
* inability to recheck the patient

Primary outcomes:
measure: 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.
timeFrame: Change from Baseline one month after surgery
Secondary outcomes:
measure: Predictive factors of dry eye syndrome during cataract surgery
timeFrame: Day 1, Day 30
measure: The characteristics of dry eye syndrome
timeFrame: Day 1, Day 30
measure: Consequences on the patient's quality of life (translated questionnaire from the Ocular Surface Disease Index from 0 to 48)
timeFrame: Day 1, Day 30
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: frédéric Chiambaretta
role: PRINCIPAL_INVESTIGATOR
References: