Stability of Biometry in Meibomian Gland Dysfunction
Stability of Biometry in Patients With Meibomian Gland Dysfunction
1 other identifier
interventional
31
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 6, 2020
CompletedFirst Submitted
Initial submission to the registry
March 23, 2020
CompletedFirst Posted
Study publicly available on registry
March 26, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2023
CompletedOctober 17, 2022
October 1, 2022
3.1 years
March 23, 2020
October 12, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Effect of Lipiflow treatment on biometrical outcomes
ACTIVE COMPARATOROne eye of each patient will be treated with Lipiflow
Control eye
NO INTERVENTIONThe contralateral eye will serve as control eye
Interventions
Patients will be treated on one eye with Lipiflow
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vienna Institute for Research in Ocular Surgery
Vienna, Austria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 23, 2020
First Posted
March 26, 2020
Study Start
February 6, 2020
Primary Completion
March 31, 2023
Study Completion
September 30, 2023
Last Updated
October 17, 2022
Record last verified: 2022-10