ClinicalTrials.gg
CompletedNCT03372759Updated Mar 5, 2018

Tilt of the Intraocular Lens in Patients Undergoing Combined Phacoemulsification and Vitrectomy With Airtamponade

An interventional study of airtamponade and saline in Epiretinal Membrane, sponsored by Vienna Institute for Research in Ocular Surgery. Completed at 1 site in Austria. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2018-03-05.

Sponsored by Vienna Institute for Research in Ocular Surgery · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies in Epiretinal Membrane by Vienna Institute for Research in Ocular Surgery — 1 open to participants now, 2 under way, none of them phase 3. Epiretinal Membrane · Vienna Institute for Research in Ocular Surgery.

Started
2015
with 1 other
No phase
8 of 10
1 open now
Registered
2nd of 10
by date

Among the 10 studies in Epiretinal Membrane by Vienna Institute for Research in Ocular Surgery, this one is one of 2 that started in 2015, is one of 8 with no phase, and was the 2nd registered.

Epiretinal Membrane

130 studies on the registry are indexed under Epiretinal Membrane; 18 are open to participants now.

Browse Epiretinal Membrane studies →

Open to participants now

1 of the 10 studies in Epiretinal Membrane by Vienna Institute for Research in Ocular Surgery is open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

Where they have run

Who these studies take

Of the 11 Epiretinal Membrane studies recruiting now, 9 (82%) set no upper age limit and none (0%) stop at 75 or younger; 2 take children under 18; 2 take healthy volunteers.

This study: 21 Years and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 10 studies in Epiretinal Membrane by Vienna Institute for Research in Ocular Surgery, or all of them as a file.
02

Study 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.

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.

03

Conditions studied

  • Epiretinal Membrane

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04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients sheduled for combined phakoemulsification and 23G pars plana vitrectomy
  • Minimum Age of 21 years
  • written

Exclusion criteria

Exclusion Criteria:

  • none
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • Active comparator
    study group air

    airtamponade

    Procedure: airtamponade

  • Sham comparator
    study group saline

    saline

    Procedure: saline

Interventions

  • Procedureairtamponade

    airtamponade is applicated in the study group air

  • Proceduresaline

    saline is left in the study Group saline

06

What researchers measure

Primary outcomes

  1. postoperative tilt of the IOL is measured with purkinjemetry

    airtamponade has the potential to leave postoperative tilt of the IOL

    Time frame: 3 months

07

Study locations

1 site
  • VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital
    Vienna, 1140, Austria
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2015, a primary completion of May 2017 and a completion of Aug 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 8, 2016
First posted
Dec 14, 2017
Start
Dec 2015
Primary completionActual
May 2017
CompletionActual
Aug 2017
Last update
Mar 5, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03372759
Lead sponsor
Vienna Institute for Research in Ocular Surgery
Responsible party
Prim. Prof. Dr. Oliver Findl, MBA (Head of the department of Ophthalmology, principal investigator, Vienna Institute for Research in Ocular Surgery) — Principal investigator
First posted
Dec 14, 2017
Start date
Dec 2015
Primary completion
May 2017
Completion
Aug 2017
Last update
Mar 5, 2018

Study contacts

Oliver Findl, Prof
principal investigator · Vienna Institute for Research in Ocular Surgery

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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