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

NCT03923244 | Completed

• 2 other identifiers: RBHP 2018 CHIAMBARETTA2018-A02526-49
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Dry Eye Syndrome; Ocular Surface Disease

Keywords

Dry Eye Syndrome; tear film analysis; ocular surface; cataract surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  Definition and classification of a dry eye syndrome according to different severity grades with an analysis of the ocular surface

  Change from Baseline one month after surgery

Secondary Outcomes (3)

• Predictive factors of dry eye syndrome during cataract surgery

  Day 1, Day 30

• The characteristics of dry eye syndrome

  Day 1, Day 30

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

  Day 1, Day 30

Study Arms (1)

cohorte 1

EXPERIMENTAL

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.

Diagnostic Test: OSDI survey

Interventions

OSDI survey 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.

Also known as: Schirmer test, Lacrydiag test

cohorte 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Wettability

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Hydrophobic and Hydrophilic Interactions; Chemical Phenomena; Surface Properties

Study Officials

• frédéric Chiambaretta

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: April 22, 2019
• Study Start: April 1, 2019
• Primary Completion: March 6, 2020
• Study Completion: March 6, 2020
• Last Updated: April 24, 2020

Record last verified: 2020-04

Locations

FR (1)