Dry EyeNCT06120894
Strip Meniscometry in Dry Eye Evaluation
An observational study of Dry Eye and Dry Eye Disease, run by University Hospital Olomouc at 1 site in Czechia.
Trial summary
Strip meniscometry is a relatively new method for evaluating the tear meniscus. The aim of the study is to evaluate the possible effect of cataract surgery on ocular surface disease and to assess the possible benefit of strip meniscometry in the preoperative and postoperative evaluation of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye, Dry Eye Disease
- What is being tested?
- Central visual acuity, Intraocular pressure measurement and Slit lamp examination
- How many people
- 21 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Nov 2021to 30 Sep 2022
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Group will be recruited from patients who undergo cataract surgery at the Department of Ophthalmology of University Hospital Olomouc and Palacky University.
Who may be able to join
- age over 18 years
- performing of pre-operative examination before cataract surgery
- signed informed consent
Who cannot join
- use of antiglaucoma drugs
- chronic blepharitis
- previous viral keratitis
- previous keratoplasty or laser refractive surgery
- known systemic disease causing changes on ocular surface (diabetes mellitus, connective tissue disease)
- use of medication causing changes on ocular surface (antidepressant, beta blockers)
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Department of Ophthalmology, University Hospital Olomouc
Olomouc
About this study
Official title: Strip Meniscometry in Dry Eye Evaluation in Connection With Cataract Surgery
Strip meniscometry is a relatively new method for evaluating the tear meniscus. The aim of the study is to evaluate the possible effect of cataract surgery on ocular surface disease and to assess the possible benefit of strip meniscometry in the preoperative and postoperative evaluation of patients.
Read the detailed description
Cataract surgery is one of the most successful anterior segment surgeries and usually results in excellent postoperative visual acuity. However, some patients may experience symptoms of dry eye disease after a successful procedure, most commonly a foreign body sensation in the eye, intermittent pain, and blurred vision. These problems then interfere with normal daily activities and also reduce the patient's satisfaction with the surgery.
The new method for tear film examination Strip meniscometry (SM) appears to be a suitable alternative to the Schirmer test. SM values correlate with Oxford score (fluorescein staining), tear break up time test or measurement of meniscus height using anterior segment optical coherence tomography. It is a minimally invasive and rapid examination method that measures the volume of the aqueous component of the tear film.
The aim of this study is to evaluate the possible influence of cataract surgery on the development of iatrogenic OSD and to assess the contribution of a new diagnostic method, SM, for the evaluation of OSD before and after cataract surgery.
- Conditions
- Dry Eye, Dry Eye Disease
- Being tested
- Central visual acuity, Intraocular pressure measurement, Slit lamp examination, Refraction and keratometry, Optical biometry
- 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.
Central visual acuityDiagnostic test
Measurement of central visual acuity using Snellen optotype chart.
Intraocular pressure measurementDiagnostic test
Measurement of intraocular pressure using non-contact Canon TX-20P tonometer.
Slit lamp examinationDiagnostic test
Slit lamp examination of the anterior and posterior segment of the eye after pharmacological dilation of the pupil using application of short-time mydriatics (1% tropicamide and 10% phenylephrine).
Refraction and keratometryDiagnostic test
Measurement of refraction and keratometry using refractometer Nidek ARK-1a.
Optical biometryDiagnostic test
Measurement of optical biometry using biometer Argos (Barrett or SRK/T formula).
Strip meniscometry (SM)Diagnostic test
Strip meniscometry examination using strip meniscometry tube.
Lid Parallel Conjunctival Folds test (LIPCOF)Diagnostic test
Evaluation of lid parallel conjunctival folds using slit lamp examination.
Staining of the ocular surface with fluoresceinDiagnostic test
Evaluation of ocular surface fluorescein staining using Oxford scheme.
Tear break up time test (TBUT)Diagnostic test
Evaluation of tear break up time using slit lamp examination.
Ocular Surface Disease Index questionnaire (OSDI)Other
Evaluation of Ocular Surface Disease Index using Ocular Surface Disease Index questionnaire.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in strip meniscometry.
Strip Meniscometry Tube in millimeters.
Measured: Week 1, 4, 12
Secondary outcomes (4)
Change in ocular surface fluorescein staining.
Oxford scheme grading with range from 0 (none staining dots) to 5 (severe dry eye).
Measured: Week 1, 4, 12
Change in tear film stability.
Tear break up time test in seconds.
Measured: Week 1, 4, 12
Change in lid-parallel conjunctival folds evaluation.
Lid-parallel conjunctival folds (LIPCOF) grading from 0 (no conjunctival folds) to 3 (more than two permanent and clear parallel folds (normally higher than 0.2 mm).
Measured: Week 1, 4, 12
Change in Ocular Surface Disease Index.
Ocular Surface Disease Index (OSDI) questionnaire with range from 0 to 100 (higher score represents greater disability).
Measured: Week 1, 4, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Nov 2021
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Olomouc
- Sponsor type
- University, hospital or other
- Collaborators
- Palacky University
- Responsible party
- Principal investigator, Zuzana Schreiberova, University Hospital Olomouc
- Investigators
- Marta Karhanova, MD, PhD, Principal investigator, University Hospital Olomouc and Palacky University Olomouc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06120894
- Sponsor's protocol ID
- 24/22
- Status last verified
- Nov 2023
- First submitted
- 1 Nov 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strip Meniscometry in Dry Eye Evaluation in Connection With Cataract Surgery
- ClinicalTrials.gov ID
- NCT06120894
- Acronym / sponsor ID
- 24/22
- Conditions
- Dry Eye, Dry Eye Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Hospital OlomoucUniversity, hospital or other
- Collaborators
- Palacky University
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 7 Nov 2023 (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.
Strip meniscometry is a relatively new method for evaluating the tear meniscus. The aim of the study is to evaluate the possible effect of cataract surgery on ocular surface disease and to assess the possible benefit of strip meniscometry in the preoperative and postoperative evaluation of patients.
Detailed description
Cataract surgery is one of the most successful anterior segment surgeries and usually results in excellent postoperative visual acuity. However, some patients may experience symptoms of dry eye disease after a successful procedure, most commonly a foreign body sensation in the eye, intermittent pain, and blurred vision. These problems then interfere with normal daily activities and also reduce the patient's satisfaction with the surgery.
The new method for tear film examination Strip meniscometry (SM) appears to be a suitable alternative to the Schirmer test. SM values correlate with Oxford score (fluorescein staining), tear break up time test or measurement of meniscus height using anterior segment optical coherence tomography. It is a minimally invasive and rapid examination method that measures the volume of the aqueous component of the tear film.
The aim of this study is to evaluate the possible influence of cataract surgery on the development of iatrogenic OSD and to assess the contribution of a new diagnostic method, SM, for the evaluation of OSD before and after cataract surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Group will be recruited from patients who undergo cataract surgery at the Department of Ophthalmology of University Hospital Olomouc and Palacky University.
Key inclusion criteria (3 listed)
- age over 18 years
- performing of pre-operative examination before cataract surgery
- signed informed consent
Key exclusion criteria (6 listed)
- use of antiglaucoma drugs
- chronic blepharitis
- previous viral keratitis
- previous keratoplasty or laser refractive surgery
- known systemic disease causing changes on ocular surface (diabetes mellitus, connective tissue disease)
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 |
|---|---|---|
| Central visual acuityMeasurement of central visual acuity using Snellen optotype chart. | Diagnostic test | – |
| Intraocular pressure measurementMeasurement of intraocular pressure using non-contact Canon TX-20P tonometer. | Diagnostic test | – |
| Slit lamp examinationSlit lamp examination of the anterior and posterior segment of the eye after pharmacological dilation of the pupil using application of short-time mydriatics (1% tropicamide and 10% phenylephrine). | Diagnostic test | – |
| Refraction and keratometryMeasurement of refraction and keratometry using refractometer Nidek ARK-1a. | Diagnostic test | – |
| Optical biometryMeasurement of optical biometry using biometer Argos (Barrett or SRK/T formula). | Diagnostic test | – |
| Strip meniscometry (SM)Strip meniscometry examination using strip meniscometry tube. | Diagnostic test | – |
| Lid Parallel Conjunctival Folds test (LIPCOF)Evaluation of lid parallel conjunctival folds using slit lamp examination. | Diagnostic test | – |
| Staining of the ocular surface with fluoresceinEvaluation of ocular surface fluorescein staining using Oxford scheme. | Diagnostic test | – |
| Tear break up time test (TBUT)Evaluation of tear break up time using slit lamp examination. | Diagnostic test | – |
| Ocular Surface Disease Index questionnaire (OSDI)Evaluation of Ocular Surface Disease Index using Ocular Surface Disease Index questionnaire. | Other | – |
Primary outcome
Change in strip meniscometry.
Time frame: Week 1, 4, 12
Strip Meniscometry Tube in millimeters.
4 secondary outcomes
Change in ocular surface fluorescein staining.
Time frame: Week 1, 4, 12
Change in tear film stability.
Time frame: Week 1, 4, 12
Change in lid-parallel conjunctival folds evaluation.
Time frame: Week 1, 4, 12
Change in Ocular Surface Disease Index.
Time frame: Week 1, 4, 12
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 7 Nov 2023.
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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.
Marta Karhanova, MD, PhD principal investigator
University Hospital Olomouc and Palacky University Olomouc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye and Dry Eye Disease, run by University Hospital Olomouc at 1 site in Czechia.
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 3 inclusion and 6 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 7 Nov 2023. 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 Czechia. 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?
Change in strip meniscometry. (time frame: Week 1, 4, 12). 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 7 Nov 2023.