Dry Eye SyndromeC-SS0NCT03923244
Dry Eye Syndrome Description During Cataract Surgery, With Multimodal Analysis of the Ocular Surface
A study testing OSDI survey in people with Dry Eye Syndrome and Ocular Surface Disease, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndrome, Ocular Surface Disease
- What is being tested?
- OSDI survey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2019to 6 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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)
- 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
- Being tested
- OSDI survey
- Keywords
- Dry Eye Syndrome, tear film analysis, ocular surface, cataract surgery
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSDI surveyDiagnostic test
Also called Schirmer test, Lacrydiag 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: OSDI survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from Baseline one month after surgery
Secondary outcomes (3)
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
Measured: Day 1, Day 30
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)
- 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.
Measured: Day 1, Day 30
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.
Measured: Day 1, Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start1 Apr 2019
- Primary completion6 Mar 2020
- Study completion6 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- frédéric Chiambaretta, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03923244
- Sponsor's protocol ID
- RBHP 2018 CHIAMBARETTA
- Other IDs
- 2018-A02526-49
- Acronym
- C-SS0
- Status last verified
- Apr 2020
- First submitted
- 5 Apr 2019
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dry Eye Syndrome Description During Cataract Surgery, With Multimodal Analysis of the Ocular Surface
- ClinicalTrials.gov ID
- NCT03923244
- Acronym / sponsor ID
- C-SS0 / RBHP 2018 CHIAMBARETTA
- Conditions
- Dry Eye Syndrome, Ocular Surface Disease
- Keywords
- Dry Eye Syndrome, tear film analysis, ocular surface, cataract surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 6 Mar 2020 (actual)
- Study completion
- 6 Mar 2020 (actual)
- First posted
- 22 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
- 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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| cohorte 1 | Experimental | Diagnostic Test: OSDI surveyNormal 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OSDI surveyAlso: Schirmer test, Lacrydiag testNormal 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 | cohorte 1 |
Primary outcome
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.
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
3 secondary outcomes
Predictive factors of dry eye syndrome during cataract surgery
Time frame: Day 1, Day 30
The characteristics of dry eye syndrome
Time frame: Day 1, Day 30
Consequences on the patient's quality of life (translated questionnaire from the Ocular Surface Disease Index from 0 to 48)
Time frame: Day 1, Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
frédéric Chiambaretta principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OSDI survey in people with Dry Eye Syndrome and Ocular Surface Disease, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Change from Baseline one month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.