Stability of Biometry in Meibomian Gland Dysfunction

NCT ID: NCT04322656

Last Updated: 2022-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-06

Study Completion Date

2023-09-30

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.

Conditions

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Meibomian Gland Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Effect of Lipiflow treatment on biometrical outcomes

One eye of each patient will be treated with Lipiflow

Group Type ACTIVE_COMPARATOR

Lipiflow treatment

Intervention Type DEVICE

Patients will be treated on one eye with Lipiflow

Control eye

The contralateral eye will serve as control eye

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lipiflow treatment

Patients will be treated on one eye with Lipiflow

Intervention Type DEVICE

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vienna Institute for Research in Ocular Surgery

OTHER

Sponsor Role lead

Responsible Party

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Prim. Prof. Dr. Oliver Findl, MBA

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Vienna Institute for Research in Ocular Surgery

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Oliver Findl, Univ.Prof. Dr.

Role: CONTACT

+43 1 91021-84611

Stefan Palkovits, Priv.Doz. Dr.

Role: CONTACT

+43 1 91021-84611

Facility Contacts

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Oliver Findl, Univ.Prof. Dr.

Role: primary

+43 1 91021-84611

Other Identifiers

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LPF

Identifier Type: -

Identifier Source: org_study_id

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