Stability of Biometry in Meibomian Gland Dysfunction

Meibomian Gland Dysfunction Clinical Trial

Official title:

Stability of Biometry in Patients With Meibomian Gland Dysfunction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04322656
• Other study ID #: LPF
• Status: Recruiting
• Phase: N/A
• Start date: February 6, 2020
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2022
• Source: Vienna Institute for Research in Ocular Surgery
• Contact: Oliver Findl, Univ.Prof. Dr.
• Phone: +43 1 91021-84611
• Email: oliver[@]findl.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 31
• Est. completion date: September 30, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Meibomian Gland Dysfunction

Intervention

Device:
• Lipiflow treatment
Patients will be treated on one eye with Lipiflow

Locations

Country	Name	City	State
Austria	Vienna Institute for Research in Ocular Surgery	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Vienna Institute for Research in Ocular Surgery

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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