Stability of Biometry in Meibomian Gland Dysfunction

Not Applicable

Recruiting

• Conditions: Meibomian Gland Dysfunction
• Interventions: Device: Lipiflow treatment

• Registration Number: NCT04322656
• Lead Sponsor: Vienna Institute for Research in Ocular Surgery

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.

Study Timeline

• Study Start: 2020-02-06
• Study First Submitted: 2020-03-23
• Study First Submitted QC: 2020-03-25
• Study First Posted: 2020-03-26
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-12
• Last Update Posted: 2022-10-17
• Primary Completion: 2023-03-31
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Effect of Lipiflow treatment on biometrical outcomes	Lipiflow treatment	One eye of each patient will be treated with Lipiflow

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Vienna Institute for Research in Ocular Surgery; 🇦🇹 Vienna, Austria