Epiretinal Membrane and Cystoid Macular Oedema Post-cataract Surgery (EPIC)

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.

Study Overview

• Status: Completed
• Conditions: Epiretinal Membrane; Pseudophakic Cystoid Macular Oedema
• Intervention / Treatment: Drug: topical (eye drop) anti-inflammatories

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 Type: Observational
• Enrollment (Actual): 123

Contacts and Locations

Study Locations

• United Kingdom
  • Portsmouth, United Kingdom, PO6 3LY
    • Portsmouth Hospitals Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with cystoid macular oedema (CMO) within 12 weeks of undergoing cataract surgery

Description

Inclusion Criteria:

1. Male or Female, aged 18 years or above.

2. 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)
3. 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.
4. Started on treatment for cystoid macular oedema
5. Participant is willing and able to give informed consent for participation in the study

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CMO without epiretinal membrane; Subject diagnosed with CMO within 12 weeks of cataract surgery without evidence of epiretinal membrane at the time of diagnosis.	Drug: topical (eye drop) anti-inflammatories; Initial treatment with topical anti-inflammatory eye drops at the discretion of the reviewing clinician
CMO with epiretinal membrane; Subject diagnosed with CMO within 12 weeks of cataract surgery with evidence of epiretinal membrane at the time of diagnosis.	Drug: topical (eye drop) anti-inflammatories; Initial treatment with topical anti-inflammatory eye drops at the discretion of the reviewing clinician

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
proportion of CMO cases that resolve within 3-, 6-, and 12-months		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	12 months
Visual Acuity	To determine visual outcomes for patients with pseudophakic CMO and to compare these between patients with and without ERM	12 months

Collaborators and Investigators

• Sponsor: Portsmouth Hospitals NHS Trust
• Investigators: Study Director: Yit Fung Yang, Portsmouth Hospitals Trust

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2018
• Primary Completion (Actual): July 13, 2022
• Study Completion (Actual): July 15, 2022

Study Registration Dates

• First Submitted: July 13, 2018
• First Submitted That Met QC Criteria: May 24, 2019
• First Posted (Actual): May 28, 2019

Study Record Updates

• Last Update Posted (Actual): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 30, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: cataract surgery
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema; Epiretinal Membrane; Pharmaceutical Solutions; Anti-Inflammatory Agents; Ophthalmic Solutions
• Other Study ID Numbers: EPIC1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No