Stability of Biometry in Meibomian Gland Dysfunction

Sponsor

Vienna Institute for Research in Ocular Surgery (Other)

Overall Status

Unknown status

CT.gov ID

NCT04322656

Collaborator

(none)

Enrollment

Location

Arms

19.8

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndrome Caused by Meibomian Gland Dysfunction	Device: Lipiflow treatment	N/A

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 Design

Study Type:

Interventional

Anticipated 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 :

Feb 6, 2020

Anticipated Primary Completion Date :

Mar 31, 2021

Anticipated Study Completion Date :

Sep 30, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Spherical and toric IOL power selected at baseline and at 3 months visit [12 months]
The difference between pre- and post-treatment biometrical calculated IOL power will be calculated and compared

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 99 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vienna Institute for Research in Ocular Surgery	Vienna		Austria

Sponsors and Collaborators

Vienna Institute for Research in Ocular Surgery

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

First Posted:

Mar 26, 2020

Last Update Posted:

Mar 26, 2020

Last Verified:

Mar 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Prim. Prof. Dr. Oliver Findl, MBA, Principal Investigator, Vienna Institute for Research in Ocular Surgery

Lipiflow

Meibomian gland dysfunction

Biometry

Additional relevant MeSH terms:

Dry Eye Syndromes

Meibomian Gland Dysfunction

Study Results

No Results Posted as of Mar 26, 2020