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

Primary Purpose

Dry Eye Syndrome, Ocular Surface Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
OSDI survey
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dry Eye Syndrome focused on measuring Dry Eye Syndrome, tear film analysis, ocular surface, cataract surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU de Clermont-Ferrand

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

cohorte 1

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Predictive factors of dry eye syndrome during cataract surgery
Measurements with a Questionnaire to collect information about : Age Gender General history / Systemic diseases / Eye diseases o General and topical medication Type of anesthesia used for surgery
The characteristics of dry eye syndrome
Incidence of dry eye syndrome before and after surgery (up to 1 month) in our centre O Correlation between subjective criteria (OSDI score) and objectives (results of evaluation by non-invasive tests) o Comparison on a sample of patients (without adelphic eye pathology) in cataract surgery between the two eyes to exclude any bias attributable to the measurement sequence independently of the surgery.
Consequences on the patient's quality of life (translated questionnaire from the Ocular Surface Disease Index from 0 to 48)
Activity limitations Adaptation to the environment Post-operative satisfaction at one month For each question, the patient must answer on the frequency of the discomfort felt, from "never" to "all the time". After calculation, a score between 0 and 100 is obtained. Consensually, it is considered that the drought syndrome is obvious when the score is 18 or more, and that it is a severe from 33 to 35.

Full Information

First Posted
April 5, 2019
Last Updated
April 23, 2020
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT03923244
Brief Title
Dry Eye Syndrome Description During Cataract Surgery, With Multimodal Analysis of the Ocular Surface
Acronym
C-SS0
Official Title
Dry Eye Syndrome Description During Cataract Surgery, With Multimodal Analysis of the Ocular Surface
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
March 6, 2020 (Actual)
Study Completion Date
March 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome, Ocular Surface Disease
Keywords
Dry Eye Syndrome, tear film analysis, ocular surface, cataract surgery

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cohorte 1
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
OSDI survey
Other Intervention Name(s)
Schirmer test, Lacrydiag test
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
Definition and classification of a dry eye syndrome according to different severity grades with an analysis of the ocular surface
Time Frame
Change from Baseline one month after surgery
Secondary Outcome Measure Information:
Title
Predictive factors of dry eye syndrome during cataract surgery
Description
Measurements with a Questionnaire to collect information about : Age Gender General history / Systemic diseases / Eye diseases o General and topical medication Type of anesthesia used for surgery
Time Frame
Day 1, Day 30
Title
The characteristics of dry eye syndrome
Description
Incidence of dry eye syndrome before and after surgery (up to 1 month) in our centre O Correlation between subjective criteria (OSDI score) and objectives (results of evaluation by non-invasive tests) o Comparison on a sample of patients (without adelphic eye pathology) in cataract surgery between the two eyes to exclude any bias attributable to the measurement sequence independently of the surgery.
Time Frame
Day 1, Day 30
Title
Consequences on the patient's quality of life (translated questionnaire from the Ocular Surface Disease Index from 0 to 48)
Description
Activity limitations Adaptation to the environment Post-operative satisfaction at one month For each question, the patient must answer on the frequency of the discomfort felt, from "never" to "all the time". After calculation, a score between 0 and 100 is obtained. Consensually, it is considered that the drought syndrome is obvious when the score is 18 or more, and that it is a severe from 33 to 35.
Time Frame
Day 1, Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
frédéric Chiambaretta
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France

12. IPD Sharing Statement

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

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