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Stability of Biometry in Meibomian Gland Dysfunction

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ClinicalTrials.gov Identifier: NCT04322656
Recruitment Status : Recruiting
First Posted : March 26, 2020
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery

Brief Summary:
Accurate biometry is an essential and indispensable tool in preoperative cataract surgery setting to yield optimal postoperative refractive outcome. However, some recent studies indicate that preoperative biometry is influenced by dry eye disease (DED). Hence, the investigator's study aims to investigate the effect of the therapy of MGD using the Lipiflow® device on the stability of biometry and selection of IOL.

Condition or disease Intervention/treatment Phase
Dry Eye Syndrome Caused by Meibomian Gland Dysfunction Device: Lipiflow treatment Not Applicable

Detailed Description:
Accurate biometry is an essential and indispensable tool in preoperative cataract surgery setting to yield optimal postoperative refractive outcome. 31 Patients suffering from DED caused by MGD will be selected and allocated randomly to therapy. Patients with pre-existing DED therapy other than lubricants will be excluded. After completing prestudy-screening and baseline visit, Lipiflow® therapy is applied to the study eye. Follow-up visits will be scheduled two weeks and three months after baseline visit. Each visit includes dry eye investigations and IOL calculation by IOLmaster 700 and CSO MS-39. After each study visit an IOL will be theoretically selected.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Stability of Biometry in Patients With Meibomian Gland Dysfunction
Actual Study Start Date : February 6, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : September 30, 2021

Arm Intervention/treatment
Active Comparator: Effect of Lipiflow treatment on biometrical outcomes
One eye of each patient will be treated with Lipiflow
Device: Lipiflow treatment
Patients will be treated on one eye with Lipiflow

No Intervention: Control eye
The contralateral eye will serve as control eye



Primary Outcome Measures :
  1. Spherical and toric IOL power selected at baseline and at 3 months visit [ Time Frame: 12 months ]
    The difference between pre- and post-treatment biometrical calculated IOL power will be calculated and compared



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age older than 18 years
  • Evidence of meibomian gland dysfunction
  • Meibomian gland secretion score equal or less than 15 (for 15 glands of the lower eye lid) using the meibomian gland evaluator (see below)

Exclusion Criteria:

  • Usage of eye drops other than lubricants (e.g. antibiotics, steroids, cyclosporin-A)
  • Usage of systemic antibiotic therapy
  • Any pathology of the ocular surface except dry eye disease (e.g. corneal scarring, cornea ectasia)
  • Ocular surgery within prior 3 months
  • Ocular injury within prior 3 months
  • Ocular herpes of eye or eyelid within prior 3 months
  • Active ocular infection
  • Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months
  • Eyelid abnormalities that affect lid function
  • Ocular surface abnormality that may compromise corneal integrity
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04322656


Contacts
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Contact: Oliver Findl, Univ.Prof. Dr. +43 1 91021-84611 oliver@findl.at
Contact: Stefan Palkovits, Priv.Doz. Dr. +43 1 91021-84611 spalkovits@viros.at

Locations
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Austria
Vienna Institute for Research in Ocular Surgery Recruiting
Vienna, Austria
Contact: Oliver Findl, Univ.Prof. Dr.    +43 1 91021-84611    oliver@findl.at   
Sub-Investigator: Stefan Palkovits, Priv.Doz. Dr.         
Principal Investigator: Oliver Findl, Univ.Prof. Dr.         
Sponsors and Collaborators
Vienna Institute for Research in Ocular Surgery
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Responsible Party: Prim. Prof. Dr. Oliver Findl, MBA, Principal Investigator, Vienna Institute for Research in Ocular Surgery
ClinicalTrials.gov Identifier: NCT04322656    
Other Study ID Numbers: LPF
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery:
Lipiflow
Meibomian gland dysfunction
Biometry
Additional relevant MeSH terms:
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Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases