Epiretinal MembraneNCT04445142
Fovea ERM After Fovea-sparing ILM Peeling
An observational study of Epiretinal Membrane and Internal Limiting Membrane Wrinkling, run by Changhua Christian Hospital at 1 site in Taiwan.
Trial summary
To report cases who had received previous fovea-sparing internal limiting peeling membrane and developed secondary fovea epiretinal membrane contraction Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Epiretinal Membrane, Internal Limiting Membrane Wrinkling
- What is being tested?
- fovea-sparing internal limiting membrane peeling
- Type of treatment
- Surgery or procedure
- How many people
- 3 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2019to 30 Apr 2020
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: patients who developed secondary fovea epiretinal membrane after previous fovea-sparing internal limiting membrane surgery
Who may be able to join
- patients who developed secondary fovea epiretinal membrane after previous fovea-sparing internal limiting membrane surgery
Who cannot join
- patients who did not receive previous fovea-sparing internal limiting membrane surgery
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of ophthalmology, Changhua Christian Hospital
Changhua, 500
About this study
Official title: Severe Foveal Epiretinal Membrane Contraction After Previous Fovea-sparing Internal Limiting Membrane Peeling Surgery
To report cases who had received previous fovea-sparing internal limiting peeling membrane and developed secondary fovea epiretinal membrane contraction
Read the detailed description
Purpose: To report the rare complication of foveal epiretinal membrane (ERM) formation on residual internal limiting membrane (ILM) with severe contraction after previous fovea-sparing internal limiting membrane (ILM) peeling.
Study design: Retrospective case series Methods: We report patients who previously received fovea-sparing ILM peeling and complicated with foveal ERM formation and contraction.
- Being tested
- fovea-sparing internal limiting membrane peeling
- Keywords
- Fovea-sparing internal limiting membrane peeling, Epiretinal membrane.
- Medical subject headings
- Epiretinal Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fovea-sparing internal limiting membrane peelingProcedure or surgery
fovea-sparing internal limiting membrane peeling surgery
| Study group | Role | What they receive |
|---|---|---|
| epiretinal membrane group | Patients developed secondary fovea epiretinal membrane Receives: Procedure: fovea-sparing internal limiting membrane peeling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Snellen visual acuity change
Measured: 6 months
Optical coherence tomography finding
fovea change on optical coherence tomography
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start1 Sep 2019
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, San Ni Chen, Changhua Christian Hospital
- Investigators
- San-Ni Chen, MD, Study chair, Changhua Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04445142
- Sponsor's protocol ID
- 200402
- Status last verified
- Jun 2020
- First submitted
- 23 May 2020
- Last updated
- 24 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chen YC, Chen SN. Isolated Central Epiretinal Membrane: A Rare Complication of Fovea-Sparing Internal Limiting Membrane Peeling Technique. J Ophthalmol. 2021 Apr 14;2021:6654604. doi: 10.1155/2021/6654604. eCollection 2021.
PubMed 33936809
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Severe Foveal Epiretinal Membrane Contraction After Previous Fovea-sparing Internal Limiting Membrane Peeling Surgery
- ClinicalTrials.gov ID
- NCT04445142
- Acronym / sponsor ID
- 200402
- Keywords
- Fovea-sparing internal limiting membrane peeling, Epiretinal membrane.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 24 Jun 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.
To report cases who had received previous fovea-sparing internal limiting peeling membrane and developed secondary fovea epiretinal membrane contraction
Detailed description
Purpose: To report the rare complication of foveal epiretinal membrane (ERM) formation on residual internal limiting membrane (ILM) with severe contraction after previous fovea-sparing internal limiting membrane (ILM) peeling.
Study design: Retrospective case series Methods: We report patients who previously received fovea-sparing ILM peeling and complicated with foveal ERM formation and contraction.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| epiretinal membrane group | – | Procedure: fovea-sparing internal limiting membrane peelingPatients developed secondary fovea epiretinal membrane |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- patients who developed secondary fovea epiretinal membrane after previous fovea-sparing internal limiting membrane surgery
Key inclusion criteria (1 listed)
- patients who developed secondary fovea epiretinal membrane after previous fovea-sparing internal limiting membrane surgery
Key exclusion criteria (1 listed)
- patients who did not receive previous fovea-sparing internal limiting membrane surgery
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 |
|---|---|---|
| fovea-sparing internal limiting membrane peelingfovea-sparing internal limiting membrane peeling surgery | Procedure or surgery | epiretinal membrane group |
Primary outcome
Visual acuity
Time frame: 6 months
Snellen visual acuity change
Optical coherence tomography finding
Time frame: 6 months
fovea change on optical coherence tomography
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 24 Jun 2020.
- Derived from this study: PubMed 33936809Chen YC, Chen SN. Isolated Central Epiretinal Membrane: A Rare Complication of Fovea-Sparing Internal Limiting Membrane Peeling Technique. J Ophthalmol. 2021 Apr 14;2021:6654604. doi: 10.1155/2021/6654604. eCollection 2021.
- 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.
San-Ni Chen, MD study chair
Changhua Christian Hospital
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 Membrane and Internal Limiting Membrane Wrinkling, run by Changhua Christian Hospital at 1 site in Taiwan.
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 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 24 Jun 2020. 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 Taiwan. 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?
Visual acuity (time frame: 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?
On the ClinicalTrials.gov record for NCT04445142, which also lists 1 linked publication.
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 24 Jun 2020.