'Distortion as a Predictor of ERM Surgery Outcome'

NCT04791631 | Unknown DMC

• 1 other identifier: GN18OP439
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Epiretinal membranes (ERM) consist of an abnormal growth of tissue across the retina and are present about 6% of people aged 50 and over. They can cause symptoms of distortion (straight lines appearing bent) or blurred vision. Management options include observation if asymptomatic, or surgery to peel the membrane if symptomatic. Limited data exists regarding how to identify patients who are most likely to benefit from surgery. We propose to measure the effects on distortion (using D chart), visual acuity and vision-related quality of life (using a validated vision-related quality of life questionnaire) of ERM surgery. This will allow us to investigate whether pre-operative D chart score can predict subsequent improvement in quality of life following surgery. We hope the results will help patients and VR surgeons decide whether or not to proceed with ERM surgery. The study will be a prospective case series consisting of patients with symptomatic epiretinal membranes who choose to have epiretinal membrane surgery. The study participants will get standard care with the additional administration of a quality of life questionnaire and measurement of distortion (using a D-chart) at 3 different time points (pre-op, and post-op at 26 and 52 weeks). Recruitment will be in Glasgow, with a possibility of other sites being added on at a later stage.

Conditions

Epiretinal Membrane; Distortion; Quality of Life

Outcome Measures

Primary Outcomes (1)

• VFQ-25 score at final visit (52 weeks after ERM surgery)

  Measure of vision-related quality of life using NEI VFQ-25 quality of life questionnaire, 1 year after surgery for epiretinal membrane

  1 year

Secondary Outcomes (4)

• Distortion score pre-operatively and at 26 and 52 weeks after ERM surgery

  1 year

• Best-corrected visual acuity pre-operatively and at 26 and 52 weeks after ERM surgery

  1 year

• Vision-related quality of life pre-operatively and at 26 and 52 weeks after ERM surgery

  1 year

• Central retinal thickness pre-operatively and at 26 and 52 weeks after ERM surgery

  1 year

Interventions

Epiretinal membrane surgery PROCEDURE

Surgery for epiretinal membrane i.e. standard 3-port pars plana vitrectomy and epiretinal membrane and internal limiting membrane peel. Phakic patients will undergo cataract surgery.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with epiretinal membranes attending the vitreoretinal clinic at the Tennent Institute of Ophthalmology in Glasgow, UK, and meeting the inclusion criteria.

You may qualify if:

• Idiopathic epiretinal membrane
• Patients undergoing vitrectomy and gas surgery, under local or general anaesthetic
• Able to give informed consent
• years old and over

You may not qualify if:

• Epiretinal membrane secondary to retinal detachment, uveitis or retinal vascular disease
• Previous vitreoretinal surgery
• Pre-existing ophthalmic condition which limits the patient's visual acuity (Documented BCVA 6/36 or worse)
• Pre-existing ophthalmic conditions which cause metamorphopsia (exudative ARMD, central serous retinopathy)
• VA \< 6/60

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• Royal College of Surgeons of Edinburgh: collaborator

Study Sites (1)

NHS Greater Glasgow and Clyde Clinical Research and Development Central Office

Paisley, PA2 7DE, United Kingdom

Location

Related Publications (13)

• Dawson SR, Shunmugam M, Williamson TH. Visual acuity outcomes following surgery for idiopathic epiretinal membrane: an analysis of data from 2001 to 2011. Eye (Lond). 2014 Feb;28(2):219-24. doi: 10.1038/eye.2013.253. Epub 2013 Dec 6.

  PMID: 24310238 BACKGROUND

• Wong JG, Sachdev N, Beaumont PE, Chang AA. Visual outcomes following vitrectomy and peeling of epiretinal membrane. Clin Exp Ophthalmol. 2005 Aug;33(4):373-8. doi: 10.1111/j.1442-9071.2005.01025.x.

  PMID: 16033349 BACKGROUND

• Pournaras CJ, Emarah A, Petropoulos IK. Idiopathic macular epiretinal membrane surgery and ILM peeling: anatomical and functional outcomes. Semin Ophthalmol. 2011 Mar;26(2):42-6. doi: 10.3109/08820538.2010.544237.

  PMID: 21469962 BACKGROUND

• Rahman R, Stephenson J. Early surgery for epiretinal membrane preserves more vision for patients. Eye (Lond). 2014 Apr;28(4):410-4. doi: 10.1038/eye.2013.305. Epub 2014 Jan 10.

  PMID: 24406414 BACKGROUND

• Ghazi-Nouri SM, Tranos PG, Rubin GS, Adams ZC, Charteris DG. Visual function and quality of life following vitrectomy and epiretinal membrane peel surgery. Br J Ophthalmol. 2006 May;90(5):559-62. doi: 10.1136/bjo.2005.085142. Epub 2006 Jan 18.

  PMID: 16421185 BACKGROUND

• Ichikawa Y, Imamura Y, Ishida M. Associations of aniseikonia with metamorphopsia and retinal displacements after epiretinal membrane surgery. Eye (Lond). 2018 Feb;32(2):400-405. doi: 10.1038/eye.2017.201. Epub 2017 Sep 22.

  PMID: 28937146 BACKGROUND

• Kinoshita T, Imaizumi H, Miyamoto H, Okushiba U, Hayashi Y, Katome T, Mitamura Y. Changes in metamorphopsia in daily life after successful epiretinal membrane surgery and correlation with M-CHARTS score. Clin Ophthalmol. 2015 Feb 4;9:225-33. doi: 10.2147/OPTH.S76847. eCollection 2015.

  PMID: 25678770 BACKGROUND

• Okamoto F, Okamoto Y, Hiraoka T, Oshika T. Effect of vitrectomy for epiretinal membrane on visual function and vision-related quality of life. Am J Ophthalmol. 2009 May;147(5):869-74, 874.e1. doi: 10.1016/j.ajo.2008.11.018. Epub 2009 Feb 6.

  PMID: 19200531 BACKGROUND

• McGowan G, Yorston D, Strang NC, Manahilov V. D-CHART: A Novel Method of Measuring Metamorphopsia in Epiretinal Membrane and Macular Hole. Retina. 2016 Apr;36(4):703-8. doi: 10.1097/IAE.0000000000000778.

  PMID: 26441261 BACKGROUND

• Klein R, Moss SE, Klein BE, Gutierrez P, Mangione CM. The NEI-VFQ-25 in people with long-term type 1 diabetes mellitus: the Wisconsin Epidemiologic Study of Diabetic Retinopathy. Arch Ophthalmol. 2001 May;119(5):733-40. doi: 10.1001/archopht.119.5.733.

  PMID: 11346401 BACKGROUND

• Nichols KK, Mitchell GL, Zadnik K. Performance and repeatability of the NEI-VFQ-25 in patients with dry eye. Cornea. 2002 Aug;21(6):578-83. doi: 10.1097/00003226-200208000-00009.

  PMID: 12131034 BACKGROUND

• Orr P, Rentz AM, Margolis MK, Revicki DA, Dolan CM, Colman S, Fine JT, Bressler NM. Validation of the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) in age-related macular degeneration. Invest Ophthalmol Vis Sci. 2011 May 18;52(6):3354-9. doi: 10.1167/iovs.10-5645.

  PMID: 21282568 BACKGROUND

• Owen CG, Rudnicka AR, Smeeth L, Evans JR, Wormald RP, Fletcher AE. Is the NEI-VFQ-25 a useful tool in identifying visual impairment in an elderly population? BMC Ophthalmol. 2006 Jun 9;6:24. doi: 10.1186/1471-2415-6-24.

  PMID: 16764714 BACKGROUND

MeSH Terms

Conditions

Epiretinal Membrane

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Lona Jawaheer, MBChB

  NHS Greater Glasgow and Clyde

  PRINCIPAL INVESTIGATOR

• David Yorston, MBChb

  NHS Greater Glasgow and Clyde

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma McDonough

CONTACT

+44141 314 4000; Emma.McDonough@ggc.scot.nhs.uk

Lona Jawaheer

CONTACT

+447783520779; lonajawaheer@nhs.net

Study Design

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

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: March 10, 2021
• Study Start: April 1, 2021
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)