Epiretinal MembraneNCT03372759
Tilt of the Intraocular Lens in Patients Undergoing Combined Phacoemulsification and Vitrectomy With Airtamponade
A study testing airtamponade and saline in people with Epiretinal Membrane, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
Trial summary
Vitrectomy with membrane peeling has developed to be the gold-standard in treatment of epiretinal membranes. Due to the possibility of vitrectomy induced cataract, in many ophthalmic surgical centers it has become usual to indicate combined phacoemulsification and vitrectomy in case of existing cataract. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Epiretinal Membrane
- What is being tested?
- airtamponade and saline
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteAustria
- Study dates
- Dec 2015to Aug 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients sheduled for combined phakoemulsification and 23G pars plana vitrectomy
- Minimum Age of 21 years
- written informed consent
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Austria1 site
VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital
Vienna, 1140
About this study
Vitrectomy with membrane peeling has developed to be the gold-standard in treatment of epiretinal membranes. Due to the possibility of vitrectomy induced cataract, in many ophthalmic surgical centers it has become usual to indicate combined phacoemulsification and vitrectomy in case of existing cataract.
Epiretinal membranes (ERM) and pseudomaculaforamen are disorders involving the posterior pole of the eyeball with consecutive vision loss. ERM can be well visualized with spectral domain optical coherence tomography (SD-OCT). Different study groups showed that even intraoperative use of SD-OCT is possible.
Read the detailed description
The aim of the study is to document tilt of the intraocular lens in combined phacoemulsification and vitrectomy by photography of purkinjereflexes. During vitrectomy tamonade with air or saline are regarded as equal in substituting the removed vitreous. In case of airtamponade, air will be resolved within several days. As airtamponade induces more anterior movement of the implanted intraocular lens in the superior parts of the lens, tilt can result. Saline doesn´t have any influence on the intraocular lens.
- Conditions
- Epiretinal Membrane
- Being tested
- airtamponade, saline
- Medical subject headings
- Epiretinal Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
airtamponadeProcedure or surgery
airtamponade is applicated in the study group air
salineProcedure or surgery
saline is left in the study Group saline
| Study group | Role | What they receive |
|---|---|---|
| study group air | Active comparator | airtamponade Receives: Procedure: airtamponade |
| study group saline | Sham comparator | saline Receives: Procedure: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative tilt of the IOL is measured with purkinjemetry
airtamponade has the potential to leave postoperative tilt of the IOL
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study startDec 2015
- Primary completionMay 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epiretinal MembraneStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
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
- Investigators
- Oliver Findl, Prof, Principal investigator, Vienna Institute for Research in Ocular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03372759
- Sponsor's protocol ID
- til
- Status last verified
- Mar 2018
- First submitted
- 8 Nov 2016
- Last updated
- 5 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tilt of the Intraocular Lens in Patients Undergoing Combined Phacoemulsification and Vitrectomy With Airtamponade
- ClinicalTrials.gov ID
- NCT03372759
- Acronym / sponsor ID
- til
- Conditions
- Epiretinal Membrane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- May 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 14 Dec 2017 (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.
Vitrectomy with membrane peeling has developed to be the gold-standard in treatment of epiretinal membranes. Due to the possibility of vitrectomy induced cataract, in many ophthalmic surgical centers it has become usual to indicate combined phacoemulsification and vitrectomy in case of existing cataract.
Epiretinal membranes (ERM) and pseudomaculaforamen are disorders involving the posterior pole of the eyeball with consecutive vision loss. ERM can be well visualized with spectral domain optical coherence tomography (SD-OCT). Different study groups showed that even intraoperative use of SD-OCT is possible.
Detailed description
The aim of the study is to document tilt of the intraocular lens in combined phacoemulsification and vitrectomy by photography of purkinjereflexes. During vitrectomy tamonade with air or saline are regarded as equal in substituting the removed vitreous. In case of airtamponade, air will be resolved within several days. As airtamponade induces more anterior movement of the implanted intraocular lens in the superior parts of the lens, tilt can result. Saline doesn´t have any influence on the intraocular lens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group air | Active comparator | Procedure: airtamponadeairtamponade |
| study group saline | Sham comparator | Procedure: salinesaline |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients sheduled for combined phakoemulsification and 23G pars plana vitrectomy
- Minimum Age of 21 years
- written informed consent
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| airtamponadeairtamponade is applicated in the study group air | Procedure or surgery | study group air |
| salinesaline is left in the study Group saline | Procedure or surgery | study group saline |
Primary outcome
postoperative tilt of the IOL is measured with purkinjemetry
Time frame: 3 months
airtamponade has the potential to leave postoperative tilt of the IOL
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2018.
- Individual participant dataSharing planned: Undecided
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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.
Oliver Findl, Prof principal investigator
Vienna Institute for Research in Ocular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing airtamponade and saline in people with Epiretinal Membrane, 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 1 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: finished, as of the sponsor's last update on 5 Mar 2018. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative tilt of the IOL is measured with purkinjemetry (time frame: 3 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 5 Mar 2018.