Pseudophakic Cystoid Macular OedemaEPICNCT03965078
Epiretinal Membrane and Cystoid Macular Oedema Post-cataract Surgery
An observational study of Pseudophakic Cystoid Macular Oedema and Epiretinal Membrane, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
This study examines whether the presence of an epiretinal membrane affects the time to resolution, requirement for non-topical treatment, and outcome of pseudophakic cystoid macular oedema. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pseudophakic Cystoid Macular Oedema, Epiretinal Membrane
- What is being tested?
- topical (eye drop) anti-inflammatories
- How many people
- 123 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Jun 2018to 15 Jul 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients diagnosed with cystoid macular oedema (CMO) within 12 weeks of undergoing cataract surgery
Who may be able to join
- Male or Female, aged 18 years or above.
- Clinical diagnosis of visually significant pseudophakic CMO in ipsilateral eye within 12 weeks of cataract surgery.
- The clinical diagnosis needs to be made by an ophthalmologist of Grade ST3 or higher.
- Visually significant is defined as best recorded visual acuity 6/9 Snellen or worse (or LogMAR equivalent)
- An OCT has to have been undertaken and needs to show the presence of intra-retinal cysts and OCT thickness (central subfield CSF) outside normal parameters as defined by Grover et al [12] and Wolf-Schnurrbusch at al [13] (For clarity the OCT examination does not need to be undertaken on the same day as the clinical diagnosis of pseudophakic CMO. Any OCT examination undertaken after cataract surgery to the ipsilateral eye within the treatment period showing these characteristics will be acceptable to substantiate the clinical diagnosis of pseudophakic CMO.
- Started on treatment for cystoid macular oedema
- Participant is willing and able to give informed consent for participation in the study
Who cannot join
- The participant may not enter the study if there is evidence that macular oedema may have been present pre-operatively. This will include ANY of the following:
- Evidence of pre-existing macular fluid/oedema
- Active proliferative diabetic retinopathy
- Diabetic macular oedema requiring treatment in the last 2 years
- Active uveitis at the time of cataract surgery
- Neovascular age-related macular degeneration
- Active retinal vein occlusion (branch or central) as evidenced by the presence of retinal haemorrhages at the time of cataract surgery or at time of diagnosis of CMO
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epiretinal Membrane and Acute Pseudophakic Cystoid Macular Oedema: A Prospective Multi-centre Observational Study of Implications and Treatment outComes
This study examines whether the presence of an epiretinal membrane affects the time to resolution, requirement for non-topical treatment, and outcome of pseudophakic cystoid macular oedema.
Read the detailed description
Cataract surgery is the most frequently performed surgery in the NHS. Cystoid macular oedema (CMO, inflammation and fluid accumulation in the central retina) is the most common visually significant complication following cataract surgery occurring in 1-2% of cases. Many cases resolve with topical anti-inflammatory eye drops. However some cases do not respond and require more invasive treatment modalities eg injections into the eye. If CMO remains persistent this can lead to permanent visual loss. There is little current knowledge on what factors lead to persistence in some cases compared to others. Epiretinal membrane (ERM, a fibrocellular membrane that can form on the inner retina) can be associated with a similar cystoid macular oedema that often does not resolve until the ERM is removed surgically. This study aims to look at whether the presence of an ERM affects how long it takes for cystoid macular oedema to resolve following cataract surgery and the requirement for non-topical treatment modalities.
A prospective, non-interventional, observational study design is proposed. Eligible participants would be identified at one of several participating NHS hospitals in the Wessex Deanery. Subjects with evidence of CMO post-cataract surgery and commenced on treatment would be included. Treatment choice is at the discretion of the reviewing clinician and independent of the study protocol. Investigations performed would be only those conducted as part of standard care. Presence of epiretinal membrane would be determined from review of the medical records. Case- records of eligible participants would be reviewed over a 12-month period to assess response to treatment and type of treatment(s) used. Based on current surgical data recruitment would be estimated to take 18 months to achieve the 165 eligible participants to achieve statistical power.
- Being tested
- topical (eye drop) anti-inflammatories
- Keywords
- cataract surgery
- Medical subject headings
- Epiretinal Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical (eye drop) anti-inflammatoriesDrug
Initial treatment with topical anti-inflammatory eye drops at the discretion of the reviewing clinician
| Study group | Role | What they receive |
|---|---|---|
| CMO without epiretinal membrane | Subject diagnosed with CMO within 12 weeks of cataract surgery without evidence of epiretinal membrane at the time of diagnosis. Receives: Drug: topical (eye drop) anti-inflammatories | |
| CMO with epiretinal membrane | Subject diagnosed with CMO within 12 weeks of cataract surgery with evidence of epiretinal membrane at the time of diagnosis. Receives: Drug: topical (eye drop) anti-inflammatories |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to resolution of CMO after commencing treatment
The time to resolution of the CMO will be calculated from the time of commencement of treatment until the documented time of resolution (based on clinical entry and confirmation on OCT scan). The clinical notes will be accessed at 3 months, 6 months and 12 month time-points to extract this data from the intervening clinical visits. The patient will complete the study either once the CMO is determined to have resolved or at 12 months post-commencing treatment, whichever is sooner.
Measured: 1 year
Secondary outcomes (3)
proportion of CMO cases that resolve within 3-, 6-, and 12-months
Measured: 3, 6 and 12 months
proportion of CMO patients requiring non-topical treatment
To describe the proportion of CMO patients requiring non-topical treatment, to compare this proportion between patients with and without ERM, and to describe the types of treatment received
Measured: 12 months
Visual Acuity
To determine visual outcomes for patients with pseudophakic CMO and to compare these between patients with and without ERM
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start21 Jun 2018
- Primary completion13 Jul 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pseudophakic Cystoid Macular OedemaStudies 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
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Yit Fung Yang, Study director, Portsmouth Hospitals Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965078
- Sponsor's protocol ID
- EPIC1
- Acronym
- EPIC
- Status last verified
- Jun 2022
- First submitted
- 13 Jul 2018
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epiretinal Membrane and Acute Pseudophakic Cystoid Macular Oedema: A Prospective Multi-centre Observational Study of Implications and Treatment outComes
- ClinicalTrials.gov ID
- NCT03965078
- Acronym / sponsor ID
- EPIC / EPIC1
- Keywords
- cataract surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Study start
- 21 Jun 2018 (actual)
- Primary completion
- 13 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 28 May 2019 (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.
This study examines whether the presence of an epiretinal membrane affects the time to resolution, requirement for non-topical treatment, and outcome of pseudophakic cystoid macular oedema.
Detailed description
Cataract surgery is the most frequently performed surgery in the NHS. Cystoid macular oedema (CMO, inflammation and fluid accumulation in the central retina) is the most common visually significant complication following cataract surgery occurring in 1-2% of cases. Many cases resolve with topical anti-inflammatory eye drops. However some cases do not respond and require more invasive treatment modalities eg injections into the eye. If CMO remains persistent this can lead to permanent visual loss. There is little current knowledge on what factors lead to persistence in some cases compared to others. Epiretinal membrane (ERM, a fibrocellular membrane that can form on the inner retina) can be associated with a similar cystoid macular oedema that often does not resolve until the ERM is removed surgically. This study aims to look at whether the presence of an ERM affects how long it takes for cystoid macular oedema to resolve following cataract surgery and the requirement for non-topical treatment modalities.
A prospective, non-interventional, observational study design is proposed. Eligible participants would be identified at one of several participating NHS hospitals in the Wessex Deanery. Subjects with evidence of CMO post-cataract surgery and commenced on treatment would be included. Treatment choice is at the discretion of the reviewing clinician and independent of the study protocol. Investigations performed would be only those conducted as part of standard care. Presence of epiretinal membrane would be determined from review of the medical records. Case- records of eligible participants would be reviewed over a 12-month period to assess response to treatment and type of treatment(s) used. Based on current surgical data recruitment would be estimated to take 18 months to achieve the 165 eligible participants to achieve statistical power.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CMO without epiretinal membrane | – | Drug: topical (eye drop) anti-inflammatoriesSubject diagnosed with CMO within 12 weeks of cataract surgery without evidence of epiretinal membrane at the time of diagnosis. |
| CMO with epiretinal membrane | – | Drug: topical (eye drop) anti-inflammatoriesSubject diagnosed with CMO within 12 weeks of cataract surgery with evidence of epiretinal membrane at the time of diagnosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with cystoid macular oedema (CMO) within 12 weeks of undergoing cataract surgery
Key inclusion criteria (7 listed)
- Male or Female, aged 18 years or above.
- Clinical diagnosis of visually significant pseudophakic CMO in ipsilateral eye within 12 weeks of cataract surgery.
- An OCT has to have been undertaken and needs to show the presence of intra-retinal cysts and OCT thickness (central subfield CSF) outside normal parameters as defined by Grover et al [12] and Wolf-Schnurrbusch at al [13] (For clarity the OCT examination does not need to be undertaken on the same day as the clinical diagnosis of pseudophakic CMO. Any OCT examination undertaken after cataract surgery to the ipsilateral eye within the treatment period showing these characteristics will be acceptable to substantiate the clinical diagnosis of pseudophakic CMO.
- Started on treatment for cystoid macular oedema
- Participant is willing and able to give informed consent for participation in the study
Key exclusion criteria (7 listed)
- The participant may not enter the study if there is evidence that macular oedema may have been present pre-operatively. This will include ANY of the following:
- Evidence of pre-existing macular fluid/oedema
- Active proliferative diabetic retinopathy
- Diabetic macular oedema requiring treatment in the last 2 years
- Active uveitis at the time of cataract 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 |
|---|---|---|
| topical (eye drop) anti-inflammatoriesInitial treatment with topical anti-inflammatory eye drops at the discretion of the reviewing clinician | Drug | CMO with epiretinal membrane, CMO without epiretinal membrane |
Primary outcome
Time to resolution of CMO after commencing treatment
Time frame: 1 year
The time to resolution of the CMO will be calculated from the time of commencement of treatment until the documented time of resolution (based on clinical entry and confirmation on OCT scan). The clinical notes will be accessed at 3 months, 6 months and 12 month time-points to extract this data from the intervening clinical visits. The patient will complete the study either once the CMO is determined to have resolved or at 12 months post-commencing treatment, whichever is sooner.
3 secondary outcomes
proportion of CMO cases that resolve within 3-, 6-, and 12-months
Time frame: 3, 6 and 12 months
proportion of CMO patients requiring non-topical treatment
Time frame: 12 months
Visual Acuity
Time frame: 12 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 3 Oct 2022.
- Individual participant dataSharing planned: No
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.
Yit Fung Yang study director
Portsmouth Hospitals Trust
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 Pseudophakic Cystoid Macular Oedema and Epiretinal Membrane, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
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 7 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 3 Oct 2022. 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 Kingdom. 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?
Time to resolution of CMO after commencing treatment (time frame: 1 year). 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 3 Oct 2022.