Meibomian Gland DysfunctionNCT04322656
Stability of Biometry in Meibomian Gland Dysfunction
A study testing Lipiflow treatment in people with Meibomian Gland Dysfunction, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
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). Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Meibomian Gland Dysfunction
- What is being tested?
- Lipiflow treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteAustria
- Study dates
- 6 Feb 2020to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Vienna Institute for Research in Ocular Surgery
Vienna
Oliver Findl, Univ.Prof. Dr., +43 1 91021-84611, oliver@findl.at
Stefan Palkovits, Priv.Doz. Dr.
About this study
Official title: Stability of Biometry in Patients With Meibomian Gland Dysfunction
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.
Read the 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.
- Conditions
- Meibomian Gland Dysfunction
- Being tested
- Lipiflow treatment
- Keywords
- Lipiflow, Meibomian gland dysfunction, Biometry
- Medical subject headings
- Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipiflow treatmentDevice
Patients will be treated on one eye with Lipiflow
| Study group | Role | What they receive |
|---|---|---|
| Effect of Lipiflow treatment on biometrical outcomes | Active comparator | One eye of each patient will be treated with Lipiflow Receives: Device: Lipiflow treatment |
| Control eye | No intervention | The contralateral eye will serve as control eye |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start6 Feb 2020
- Primary completion31 Mar 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meibomian Gland DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vienna Institute for Research in Ocular Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04322656
- Sponsor's protocol ID
- LPF
- Status last verified
- Oct 2022
- First submitted
- 23 Mar 2020
- Last updated
- 17 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stability of Biometry in Patients With Meibomian Gland Dysfunction
- ClinicalTrials.gov ID
- NCT04322656
- Acronym / sponsor ID
- LPF
- Conditions
- Meibomian Gland Dysfunction
- Keywords
- Lipiflow, Meibomian gland dysfunction, Biometry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- 6 Feb 2020 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 26 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Effect of Lipiflow treatment on biometrical outcomes | Active comparator | Device: Lipiflow treatmentOne eye of each patient will be treated with Lipiflow |
| Control eye | No intervention | –The contralateral eye will serve as control eye |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lipiflow treatmentPatients will be treated on one eye with Lipiflow | Device | Effect of Lipiflow treatment on biometrical outcomes |
Primary outcome
Spherical and toric IOL power selected at baseline and at 3 months visit
Time frame: 12 months
The difference between pre- and post-treatment biometrical calculated IOL power will be calculated and compared
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lipiflow treatment in people with Meibomian Gland Dysfunction, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oliver Findl, Univ.Prof. Dr. (+43 1 91021-84611, oliver@findl.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spherical and toric IOL power selected at baseline and at 3 months visit (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2022; AzTrials last refreshed its copy on 26 Oct 2026.