Epiretinal MembranectomyNCT01901406
Change of Retinally-Induced Aniseikonia in Patients With Epiretinal Membrane After Vitrectomy
An observational study of Epiretinal Membranectomy, run by Yonsei University at 1 site in South Korea.
Trial summary
Epiretinal membrane is common disease, affecting 5~10 % incidence over 60 years old population. It reduce visual acuity, cause metamorphopsia. In the past, vitrectomy and epiretinal membranectomy was indicated in patients with visual acuity less than 20/40, but nowadays with technical improvement and surgical… Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Epiretinal Membranectomy
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2013to Jun 2014
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with epiretinal membrane who had metamorphopsia or had imparied vision, therefore planned to undergo vitrectomy
Who may be able to join
- Idiopathic epiretinal membrane who had impaired vision or metamorphopsia, want to undergo vitrectomy
- Age more than 20 years and less than 90 years old
Who cannot join
- secondary epiretinal membrane due to retinal surgery,
- impaired visual acuity less than 20/40 in the normal eye(Snellen chart) due to severe cataract
- glaucoma patients
- complication during vitrectomy (ex. Retinal tear, silicone oil injection, …)
- other retinal disease except epiretinal membrane
- other ocular surgery history within 3 months
- intellectual problems or illiterate whom could not obtained informed consent
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Institute of Vision Research, Department of Ophthalmology, Gangnam Severance Hospital
Seoul, 135-720
About this study
Epiretinal membrane is common disease, affecting 5~10 % incidence over 60 years old population. It reduce visual acuity, cause metamorphopsia. In the past, vitrectomy and epiretinal membranectomy was indicated in patients with visual acuity less than 20/40, but nowadays with technical improvement and surgical instrument renovation, it seems to have been changed the surgical indication. Therefore, we plan to evaluate the changes of binocular visual acuity, aniseikonia in patients with epiretinal membrane.
- Conditions
- Epiretinal Membranectomy
- Keywords
- epiretinal membrane, stereopsis, aniseikonia
- Medical subject headings
- Epiretinal Membrane, Aniseikonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ERM | idiopathic epiretinal membrane patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Stereopsis tested by TNO test (arc of second)
Stereopsis is normal binocular vision. Its presence or absence is an important indicator of the state of binocularity. The TNO test is graded to provide retinal disparities ranging from 15 to 480 second of arc.
Measured: from Initial screening day before surgey to postoperative 6 months
Titmus test (arc of second)
Measured: from Initial screening day before surgey to postoperative 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epiretinal MembranectomyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01901406
- Sponsor's protocol ID
- 3-2013-0094
- Status last verified
- Aug 2014
- First submitted
- 2 Jul 2013
- Last updated
- 12 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change of Retinally-Induced Aniseikonia in Patients With Epiretinal Membrane After Vitrectomy
- ClinicalTrials.gov ID
- NCT01901406
- Acronym / sponsor ID
- 3-2013-0094
- Conditions
- Epiretinal Membranectomy
- Keywords
- epiretinal membrane, stereopsis, aniseikonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 17 Jul 2013 (estimated)
- 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.
Epiretinal membrane is common disease, affecting 5~10 % incidence over 60 years old population. It reduce visual acuity, cause metamorphopsia. In the past, vitrectomy and epiretinal membranectomy was indicated in patients with visual acuity less than 20/40, but nowadays with technical improvement and surgical instrument renovation, it seems to have been changed the surgical indication. Therefore, we plan to evaluate the changes of binocular visual acuity, aniseikonia in patients with epiretinal membrane.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ERM | – | –idiopathic epiretinal membrane patients |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with epiretinal membrane who had metamorphopsia or had imparied vision, therefore planned to undergo vitrectomy
Key inclusion criteria (2 listed)
- Idiopathic epiretinal membrane who had impaired vision or metamorphopsia, want to undergo vitrectomy
- Age more than 20 years and less than 90 years old
Key exclusion criteria (7 listed)
- secondary epiretinal membrane due to retinal surgery,
- impaired visual acuity less than 20/40 in the normal eye(Snellen chart) due to severe cataract
- glaucoma patients
- complication during vitrectomy (ex. Retinal tear, silicone oil injection, …)
- other retinal disease except epiretinal membrane
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
Changes of Stereopsis tested by TNO test (arc of second)
Time frame: from Initial screening day before surgey to postoperative 6 months
Stereopsis is normal binocular vision. Its presence or absence is an important indicator of the state of binocularity. The TNO test is graded to provide retinal disparities ranging from 15 to 480 second of arc.
Titmus test (arc of second)
Time frame: from Initial screening day before surgey to postoperative 6 months
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 12 Aug 2014.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epiretinal Membranectomy, run by Yonsei University at 1 site in South Korea.
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 2 inclusion and 7 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 12 Aug 2014. 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 South Korea. 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?
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?
Changes of Stereopsis tested by TNO test (arc of second) (time frame: from Initial screening day before surgey to postoperative 6 months). The study lists 2 primary outcomes in all. 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 12 Aug 2014.