Strip Meniscometry in Dry Eye Evaluation

Sponsor
University Hospital Olomouc (Other)
Overall Status
Completed
CT.gov ID
NCT06120894
Collaborator
Palacky University (Other)
21
1
10.9
1.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Central visual acuity
  • Diagnostic Test: Intraocular pressure measurement
  • Diagnostic Test: Slit lamp examination
  • Diagnostic Test: Refraction and keratometry
  • Diagnostic Test: Optical biometry
  • Diagnostic Test: Strip meniscometry (SM)
  • Diagnostic Test: Lid Parallel Conjunctival Folds test (LIPCOF)
  • Diagnostic Test: Staining of the ocular surface with fluorescein
  • Diagnostic Test: Tear break up time test (TBUT)
  • Other: Ocular Surface Disease Index questionnaire (OSDI)

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

Study Type:
Observational
Actual Enrollment :
21 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Strip Meniscometry in Dry Eye Evaluation in Connection With Cataract Surgery
Actual Study Start Date :
Nov 1, 2021
Actual Primary Completion Date :
Sep 30, 2022
Actual Study Completion Date :
Sep 30, 2022

Outcome Measures

Primary Outcome Measures

  1. Change in strip meniscometry. [Week 1, 4, 12]

    Strip Meniscometry Tube in millimeters.

Secondary Outcome Measures

  1. Change in ocular surface fluorescein staining. [Week 1, 4, 12]

    Oxford scheme grading with range from 0 (none staining dots) to 5 (severe dry eye).

  2. Change in tear film stability. [Week 1, 4, 12]

    Tear break up time test in seconds.

  3. Change in lid-parallel conjunctival folds evaluation. [Week 1, 4, 12]

    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).

  4. Change in Ocular Surface Disease Index. [Week 1, 4, 12]

    Ocular Surface Disease Index (OSDI) questionnaire with range from 0 to 100 (higher score represents greater disability).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • age over 18 years

  • performing of pre-operative examination before cataract surgery

  • signed informed consent

Exclusion Criteria:
  • 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Ophthalmology, University Hospital Olomouc Olomouc Czechia

Sponsors and Collaborators

  • University Hospital Olomouc
  • Palacky University

Investigators

  • Principal Investigator: Marta Karhanova, MD, PhD, University Hospital Olomouc and Palacky University Olomouc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zuzana Schreiberova, Principal Investigator, University Hospital Olomouc
ClinicalTrials.gov Identifier:
NCT06120894
Other Study ID Numbers:
  • 24/22
First Posted:
Nov 7, 2023
Last Update Posted:
Nov 7, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 7, 2023