Epiretinal MembraneNCT03404323
"Cataract Surgery in Eyes With Epiretinal Membrane"
An observational study of Epiretinal Membrane and Pseudophakic Cystoid Macular Edema, run by St John of God Hospital, Vienna.
Trial summary
The purpose of the study is to evaluate retinal thickness change and the occurrence of central structural retinal changes after uneventful small-incision cataract surgery in eyes with asymptomatic early stages of epiretinal membrane. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Epiretinal Membrane, Pseudophakic Cystoid Macular Edema, Irvine-Gass Syndrome
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2015to 1 May 2017
- Phase
- Observational
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Thirty patients with visually compromising cataract and asymptomatic epiretinal membrane (ERM group) and 15 consecutive eyes with senile cataract with a healthy macula (control group) were included.
Who may be able to join
- visually compromising cataract and asymptomatic early stages of epiretinal membrane with no structural changes such as cysts or photoreceptor distribution in optical coherence tomography.
Who cannot join
- visual impairment or metamorphopsia due to epiretinal membrane
- history of branch retinal vein occlusion
- central retinal vein occlusion
- wet or dry macular degeneration
- diabetic retinopathy
- uveitis or other inflammatory eye disease.
About this study
Official title: "Retinal Thickness Change Following Cataract Surgery in Eyes With Epiretinal Membrane"
The purpose of the study is to evaluate retinal thickness change and the occurrence of central structural retinal changes after uneventful small-incision cataract surgery in eyes with asymptomatic early stages of epiretinal membrane.
Read the detailed description
Optical coherence tomography (OCT) is nowadays used in daily clinical practice and has become a helpful tool for detection of macular changes also in presence of opacification of the lens before cataract surgery. Using recent high-resolution OCT technology, early stages of epiretinal membranes can easily be detected and analysed. Since cataract surgery is one of the most frequently performed operations worldwide, this study was aimed to investigate the influence of uncomplicated cataract surgery on central retinal thickness and the incidence of structural and morphological macular changes after surgery in eyes with asymptomatic epiretinal membrane.
- Keywords
- central retinal thickness, epiretinal membrane, cataract surgery, pseudophakic cystoid macular edema
- Medical subject headings
- Epiretinal Membrane, Macular Edema, Cataract
What is being measured
The primary outcome is the main question the study is designed to answer.
central macular thickness
Central 1-millimeter and 3-milimeter retinal thickness
Measured: Change from Baseline central macular thickness at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start1 Jul 2015
- Primary completion1 Jul 2016
- Study completion1 May 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- St John of God Hospital, Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Wetzel, St John of God Hospital, Vienna
- Investigators
- Barbara Wetzel, MD, Principal investigator, St John of God Hospital, ViennaGeorgios Mylonas, MD, Study director, St John of God Hospital, Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03404323
- Sponsor's protocol ID
- 15062015
- Status last verified
- Jan 2018
- First submitted
- 11 Jan 2018
- Last updated
- 19 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Retinal Thickness Change Following Cataract Surgery in Eyes With Epiretinal Membrane"
- ClinicalTrials.gov ID
- NCT03404323
- Acronym / sponsor ID
- 15062015
- Keywords
- central retinal thickness, epiretinal membrane, cataract surgery, pseudophakic cystoid macular edema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- St John of God Hospital, ViennaUniversity, hospital or other
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 1 Jul 2016 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 19 Jan 2018 (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.
The purpose of the study is to evaluate retinal thickness change and the occurrence of central structural retinal changes after uneventful small-incision cataract surgery in eyes with asymptomatic early stages of epiretinal membrane.
Detailed description
Optical coherence tomography (OCT) is nowadays used in daily clinical practice and has become a helpful tool for detection of macular changes also in presence of opacification of the lens before cataract surgery. Using recent high-resolution OCT technology, early stages of epiretinal membranes can easily be detected and analysed. Since cataract surgery is one of the most frequently performed operations worldwide, this study was aimed to investigate the influence of uncomplicated cataract surgery on central retinal thickness and the incidence of structural and morphological macular changes after surgery in eyes with asymptomatic epiretinal membrane.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Thirty patients with visually compromising cataract and asymptomatic epiretinal membrane (ERM group) and 15 consecutive eyes with senile cataract with a healthy macula (control group) were included.
Key inclusion criteria (1 listed)
- visually compromising cataract and asymptomatic early stages of epiretinal membrane with no structural changes such as cysts or photoreceptor distribution in optical coherence tomography.
Key exclusion criteria (6 listed)
- visual impairment or metamorphopsia due to epiretinal membrane
- history of branch retinal vein occlusion
- central retinal vein occlusion
- wet or dry macular degeneration
- diabetic retinopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
central macular thickness
Time frame: Change from Baseline central macular thickness at 3 months
Central 1-millimeter and 3-milimeter retinal thickness
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 19 Jan 2018.
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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.
Barbara Wetzel, MD principal investigator
St John of God Hospital, Vienna
Georgios Mylonas, MD study director
St John of God Hospital, Vienna
Questions about this trial
What is this clinical trial studying?
An observational study of Epiretinal Membrane and Pseudophakic Cystoid Macular Edema, run by St John of God Hospital, Vienna.
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 1 inclusion and 6 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 19 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
central macular thickness (time frame: Change from Baseline central macular thickness at 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 19 Jan 2018.