Macular EdemaNCT02693353
Epiretinal Membrane and Pseudophakic Cystoid Macular Edema
An observational study of Macular Edema and Epiretinal Membrane, run by Loma Linda University at 1 site in United States.
Trial summary
Prospective, observational cohort study evaluating the association between pre-surgical existence of an epiretinal membrane (ERM) and the development of pseudophakic cystoid macular edema (PCME) using spectral domain optical coherence tomography (OCT) measurements. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Edema, Epiretinal Membrane
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Mar 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients over 18 who are undergoing cataract surgery at Loma Linda University Eye Institute
Who may be able to join
- 18 years or older
- Cataract surgery patients
Who cannot join
- Pre-existing macular edema
- Choroidal neovascularization
- Uveitis
- Age-related macular degeneration
- Myopia > 6 diopters
- Proliferative diabetic retinopathy
- Diabetics retinopathy great than mild in serverity
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Medical Center
Loma Linda, California, 92354
About this study
Official title: Association of Cystoid Macular Edema After Cataract Surgery in Patients With and Without Epiretinal Membrane
Prospective, observational cohort study evaluating the association between pre-surgical existence of an epiretinal membrane (ERM) and the development of pseudophakic cystoid macular edema (PCME) using spectral domain optical coherence tomography (OCT) measurements.
- Conditions
- Macular Edema, Epiretinal Membrane
- Medical subject headings
- Macular Edema, Epiretinal Membrane
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 |
|---|---|---|
| Study Group | Patients with diagnosed epiretinal membrane undergoing cataract surgery. | |
| Control Group | Patients without epiretinal membrane undergoing cataract surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cystoid Macular Edema diagnosed by OCT
Measured: Within 90 days post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionMar 2019
- Study completionMar 2019
Why it stopped: Recent publication makes current study obsolete.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular EdemaStudies of the same condition, open and under way.
- More trials run by Loma Linda 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Sierpina, Loma Linda University
- Investigators
- David Sierpina, MD, Principal investigator, Loma Linda University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02693353
- Sponsor's protocol ID
- 5150420
- Status last verified
- Mar 2019
- First submitted
- 24 Feb 2016
- Last updated
- 19 Mar 2019
- 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 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Cystoid Macular Edema After Cataract Surgery in Patients With and Without Epiretinal Membrane
- ClinicalTrials.gov ID
- NCT02693353
- Acronym / sponsor ID
- 5150420
- Conditions
- Macular Edema, Epiretinal Membrane
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recent publication makes current study obsolete.
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 26 Feb 2016 (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.
Prospective, observational cohort study evaluating the association between pre-surgical existence of an epiretinal membrane (ERM) and the development of pseudophakic cystoid macular edema (PCME) using spectral domain optical coherence tomography (OCT) measurements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | –Patients with diagnosed epiretinal membrane undergoing cataract surgery. |
| Control Group | – | –Patients without epiretinal membrane undergoing cataract surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients over 18 who are undergoing cataract surgery at Loma Linda University Eye Institute
Key inclusion criteria (2 listed)
- 18 years or older
- Cataract surgery patients
Key exclusion criteria (7 listed)
- Pre-existing macular edema
- Choroidal neovascularization
- Uveitis
- Age-related macular degeneration
- Myopia > 6 diopters
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
Cystoid Macular Edema diagnosed by OCT
Time frame: Within 90 days post op
Results and safety
The study was stopped early (reason given: Recent publication makes current study obsolete.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- 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.
David Sierpina, MD principal investigator
Loma Linda University Medical Center
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 Macular Edema and Epiretinal Membrane, run by Loma Linda University at 1 site in United States.
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: stopped early, as of the sponsor's last update on 19 Mar 2019. 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 United States. 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 was stopped early (reason given: Recent publication makes current study obsolete.). Results are not available in the source record.
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?
Cystoid Macular Edema diagnosed by OCT (time frame: Within 90 days post op). 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 Mar 2019.