Stability of Biometry in Meibomian Gland Dysfunction

Study Overview
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Brief Summary
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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
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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.

Official Title
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Stability of Biometry in Patients With Meibomian Gland Dysfunction

Conditions
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Meibomian Gland Dysfunction

Intervention / Treatment
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* Device: Lipiflow treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Effect of Lipiflow treatment on biometrical outcomes<br>One eye of each patient will be treated with Lipiflow | Device: Lipiflow treatment<br>* Patients will be treated on one eye with Lipiflow<br>|
| No Intervention: Control eye<br>The contralateral eye will serve as control eye | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lipiflow, Meibomian gland dysfunction, Biometry