Epiretinal Membrane and Cystoid Macular Oedema Post-cataract Surgery

NCT03965078 | Completed

• 1 other identifier: EPIC1
• Study Type: observational
• Target: 123
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pseudophakic Cystoid Macular Oedema; Epiretinal Membrane

Keywords

cataract surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

  12 months

• Visual Acuity

  12 months

Study Arms (2)

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

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

Interventions

topical (eye drop) anti-inflammatories DRUG

Initial treatment with topical anti-inflammatory eye drops at the discretion of the reviewing clinician

CMO with epiretinal membrane; CMO without epiretinal membrane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Portsmouth Hospitals NHS Trust: lead

Study Sites (1)

Portsmouth Hospitals Trust

Portsmouth, PO6 3LY, United Kingdom

Location

MeSH Terms

Conditions

Epiretinal Membrane

Interventions

Ophthalmic Solutions; Anti-Inflammatory Agents

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Yit Fung Yang

  Portsmouth Hospitals Trust

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: May 28, 2019
• Study Start: June 21, 2018
• Primary Completion: July 13, 2022
• Study Completion: July 15, 2022
• Last Updated: October 3, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)