Stability of Biometry in Meibomian Gland Dysfunction

Stability of Biometry in Patients With Meibomian Gland Dysfunction

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.

Study Overview

• Status: Recruiting
• Conditions: Meibomian Gland Dysfunction
• Intervention / Treatment: Device: Lipiflow treatment

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.

• Study Type: Interventional
• Enrollment (Anticipated): 31
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Oliver Findl, Univ.Prof. Dr.; Phone Number: +43 1 91021-84611; Email: oliver@findl.at
• Study Contact Backup: Name: Stefan Palkovits, Priv.Doz. Dr.; Phone Number: +43 1 91021-84611; Email: spalkovits@viros.at

Study Locations

• Austria
  • Vienna, Austria
    • Recruiting
    • Vienna Institute for Research in Ocular Surgery
    • Contact: Oliver Findl, Univ.Prof. Dr.; Phone Number: +43 1 91021-84611; Email: oliver@findl.at
    • Sub-Investigator: Stefan Palkovits, Priv.Doz. Dr.
    • Principal Investigator: Oliver Findl, Univ.Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months

Collaborators and Investigators

• Sponsor: Vienna Institute for Research in Ocular Surgery

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 6, 2020
• Primary Completion (ANTICIPATED): March 31, 2023
• Study Completion (ANTICIPATED): September 30, 2023

Study Registration Dates

• First Submitted: March 23, 2020
• First Submitted That Met QC Criteria: March 25, 2020
• First Posted (ACTUAL): March 26, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 17, 2022
• Last Update Submitted That Met QC Criteria: October 12, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Meibomian gland dysfunction; Biometry; Lipiflow
• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Meibomian Gland Dysfunction
• Other Study ID Numbers: LPF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No