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Stability of Biometry in Meibomian Gland Dysfunction

Stability of Biometry in Patients With Meibomian Gland Dysfunction

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04322656
Enrollment
31
Registered
2020-03-26
Start date
2020-02-06
Completion date
2023-09-30
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meibomian Gland Dysfunction

Keywords

Lipiflow, Meibomian gland dysfunction, Biometry

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.

Interventions

Patients will be treated on one eye with Lipiflow

Sponsors

Vienna Institute for Research in Ocular Surgery
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
21 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Spherical and toric IOL power selected at baseline and at 3 months visit12 monthsThe difference between pre- and post-treatment biometrical calculated IOL power will be calculated and compared

Countries

Austria

Contacts

Primary ContactOliver Findl, Univ.Prof. Dr.
oliver@findl.at+43 1 91021-84611
Backup ContactStefan Palkovits, Priv.Doz. Dr.
spalkovits@viros.at+43 1 91021-84611

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026