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

NCT ID: NCT03923244

Last Updated: 2020-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2020-03-06

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

Conditions

Dry Eye Syndrome; Ocular Surface Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

cohorte 1

Normal patient consultation schedule for cataract surgery with:

• Preoperative appointment scheduled for the patient
• Post-operative appointment 1 month before surgery No additional appointments.

After geting consent and during the two consultations:

• Completion of a quality of life survey by the patient. Collection of the patient's history and general and ophthalmological treatments. Questionnaire of 12 items on quality of life to be completed. For each question, the patient must answer on the frequency of the discomfort felt, from "never" to "all the time".
• An analysis of the ocular surface is performed by a non-invasive and non-contact device for 4 minutes. This consists of taking different photographs of the eye and eyelids, allowing each to study a part of the tears.
• Schirmer test is performed, consisting of applying the end of a small strip of blotting paper behind the lower eyelid and examining the strip after 5 minutes.

Group Type: EXPERIMENTAL

OSDI survey

Intervention Type: DIAGNOSTIC_TEST

Normal patient consultation schedule for cataract surgery with:

• Preoperative appointment scheduled for the patient
• Post-operative appointment 1 month before surgery No additional appointments.

After geting consent and during the two consultations:

• Completion of a quality of life survey by the patient. Collection of the patient's history and general and ophthalmological treatments. Questionnaire of 12 items on quality of life to be completed. For each question, the patient must answer on the frequency of the discomfort felt, from "never" to "all the time".
• An analysis of the ocular surface is performed by a non-invasive and non-contact device for 4 minutes. This consists of taking different photographs of the eye and eyelids, allowing each to study a part of the tears.
• Schirmer test is performed, consisting of applying the end of a small strip of blotting paper behind the lower eyelid and examining the strip after 5 minutes.

Interventions

OSDI survey

Normal patient consultation schedule for cataract surgery with:

• Preoperative appointment scheduled for the patient
• Post-operative appointment 1 month before surgery No additional appointments.

After geting consent and during the two consultations:

• Completion of a quality of life survey by the patient. Collection of the patient's history and general and ophthalmological treatments. Questionnaire of 12 items on quality of life to be completed. For each question, the patient must answer on the frequency of the discomfort felt, from "never" to "all the time".
• An analysis of the ocular surface is performed by a non-invasive and non-contact device for 4 minutes. This consists of taking different photographs of the eye and eyelids, allowing each to study a part of the tears.
• Schirmer test is performed, consisting of applying the end of a small strip of blotting paper behind the lower eyelid and examining the strip after 5 minutes.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Schirmer test; Lacrydiag test

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

frédéric Chiambaretta

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Countries

France

Other Identifiers

2018-A02526-49

Identifier Type: OTHER

Identifier Source: secondary_id

RBHP 2018 CHIAMBARETTA

Identifier Type: -

Identifier Source: org_study_id