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Stability of Biometry in Meibomian Gland Dysfunction

Primary Purpose

Meibomian Gland Dysfunction

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Lipiflow treatment
Sponsored by
Vienna Institute for Research in Ocular Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meibomian Gland Dysfunction focused on measuring Lipiflow, Meibomian gland dysfunction, Biometry

Eligibility Criteria

21 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vienna Institute for Research in Ocular SurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Effect of Lipiflow treatment on biometrical outcomes

Control eye

Arm Description

One eye of each patient will be treated with Lipiflow

The contralateral eye will serve as control eye

Outcomes

Primary Outcome Measures

Spherical and toric IOL power selected at baseline and at 3 months visit
The difference between pre- and post-treatment biometrical calculated IOL power will be calculated and compared

Secondary Outcome Measures

Full Information

First Posted
March 23, 2020
Last Updated
October 12, 2022
Sponsor
Vienna Institute for Research in Ocular Surgery
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1. Study Identification

Unique Protocol Identification Number
NCT04322656
Brief Title
Stability of Biometry in Meibomian Gland Dysfunction
Official Title
Stability of Biometry in Patients With Meibomian Gland Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 6, 2020 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vienna Institute for Research in Ocular Surgery

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meibomian Gland Dysfunction
Keywords
Lipiflow, Meibomian gland dysfunction, Biometry

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
31 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Effect of Lipiflow treatment on biometrical outcomes
Arm Type
Active Comparator
Arm Description
One eye of each patient will be treated with Lipiflow
Arm Title
Control eye
Arm Type
No Intervention
Arm Description
The contralateral eye will serve as control eye
Intervention Type
Device
Intervention Name(s)
Lipiflow treatment
Intervention Description
Patients will be treated on one eye with Lipiflow
Primary Outcome Measure Information:
Title
Spherical and toric IOL power selected at baseline and at 3 months visit
Description
The difference between pre- and post-treatment biometrical calculated IOL power will be calculated and compared
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oliver Findl, Univ.Prof. Dr.
Phone
+43 1 91021-84611
Email
oliver@findl.at
First Name & Middle Initial & Last Name or Official Title & Degree
Stefan Palkovits, Priv.Doz. Dr.
Phone
+43 1 91021-84611
Email
spalkovits@viros.at
Facility Information:
Facility Name
Vienna Institute for Research in Ocular Surgery
City
Vienna
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oliver Findl, Univ.Prof. Dr.
Phone
+43 1 91021-84611
Email
oliver@findl.at
First Name & Middle Initial & Last Name & Degree
Stefan Palkovits, Priv.Doz. Dr.
First Name & Middle Initial & Last Name & Degree
Oliver Findl, Univ.Prof. Dr.

12. IPD Sharing Statement

Learn more about this trial

Stability of Biometry in Meibomian Gland Dysfunction

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