CHU de Clermont-Ferrand
Clermont-Ferrand, 63000, France
NCT Number: NCT03923244
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
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Clermont-Ferrand, 63000, France
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:
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)
Secondary Judgement Criteria: Evaluate during cataract surgery:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Normal patient consultation schedule for cataract surgery with:
After geting consent and during the two consultations:
Other names: Schirmer test, Lacrydiag test
Time frame: Change from Baseline one month after surgery
Definition and classification of a dry eye syndrome according to different severity grades with an analysis of the ocular surface
Time frame: Day 1, Day 30
Measurements with a Questionnaire to collect information about :
Time frame: Day 1, Day 30
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
Activity limitations
University Hospital, Clermont-Ferrand
Other
Acronym: C-SS0
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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