'Distortion as a Predictor of ERM Surgery Outcome'

Quality of Life Clinical Trial

Official title:

Does Pre-operative D-chart Score Predict Improvement in VFQ-25 Score Following Surgery for Epiretinal Membrane?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04791631
• Other study ID #: GN18OP439
• Status: Not yet recruiting
• Start date: April 1, 2021
• Est. completion date: April 1, 2023

Study information

• Verified date: March 2021
• Source: NHS Greater Glasgow and Clyde
• Contact: Emma McDonough
• Phone: +44141 314 4000
• Email: Emma.McDonough[@]ggc.scot.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Epiretinal membranes consist of a proliferation of fibrocellular tissue along the inner aspect of the retina. Over time, this membrane can result in anterior-posterior traction and cause disruption of the retinal architecture, which can lead to symptoms of blurred vision, or distorted vision (with straight lines appearing bent or wavy).

Patients with ERM now constitute one of the most common referrals to the vitreoretinal service. Management of epiretinal membrane includes observation or surgery for severely symptomatic membranes. The surgery consists of vitrectomy and epiretinal +/- inner limiting membrane peel. Currently there is limited evidence to help identify which patients with an epiretinal membrane are the most likely to benefit from this operation, which makes it more difficult for patients to be able to weigh up the benefits and risks of proceeding with this elective procedure.

Our study will measure the effects on distortion (using D chart), visual acuity and quality of life of ERM surgery. Hence it will allow us to investigate whether the pre-op D chart score can predict subsequent improvement in quality of life following surgery. This will provide vitreoretinal surgeons and patients with an evidence base regarding the success of this elective procedure and offer realistic expectations regarding surgical outcomes. Ultimately, we hope that the results of this study will facilitate the decision of whether or not to proceed with ERM surgery.

We plan to recruit patients with an epiretinal membrane who choose to undergo surgery at the time of their clinic appointment within the vitreoretinal service. In addition to standard care, the study participants will undergo measurements of distortion (using a D-chart, duration 5-10 minutes) and fill in a quality of life questionnaire. These measurements will be taken before the operation and at six and twelve months following the operation.

The aims of the study are:

• To investigate the sustained effect of epiretinal membrane surgery on distortion (using D-chart), visual acuity and vision-related quality of life (using NEI VFQ-25 questionnaire)

• To determine the relationship between pre-operative distortion score and post-operative vision-related quality of life score following ERM surgery

Our study will have a larger number of participants with a longer period of follow up (52 weeks) than comparable studies. It will be the first epiretinal membrane study that measures distortion using the D-chart, which we believe to be superior to existing tests (such as the M-chart) which have been used in similar studies.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Idiopathic epiretinal membrane

2. Patients undergoing vitrectomy and gas surgery, under local or general anaesthetic

3. Able to give informed consent

4. 18 years old and over

Exclusion Criteria:

1. Epiretinal membrane secondary to retinal detachment, uveitis or retinal vascular disease

2. Previous vitreoretinal surgery

3. Pre-existing ophthalmic condition which limits the patient's visual acuity (Documented BCVA 6/36 or worse)

4. Pre-existing ophthalmic conditions which cause metamorphopsia (exudative ARMD, central serous retinopathy)

5. VA < 6/60

Related Conditions & MeSH terms

• Distortion
• Epiretinal Membrane
• Quality of Life

Intervention

Procedure:
• Epiretinal membrane surgery
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.

Locations

Country	Name	City	State
United Kingdom	NHS Greater Glasgow and Clyde Clinical Research and Development Central Office	Paisley

Sponsors (2)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde	Royal College of Surgeons of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

References & 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. — View Citation

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. Epub 2006 Jan 18. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Distortion score pre-operatively and at 26 and 52 weeks after ERM surgery	Distortion score calculated using D-chart	1 year
Secondary	Best-corrected visual acuity pre-operatively and at 26 and 52 weeks after ERM surgery	Visual acuity measured in ETDRS	1 year
Secondary	Vision-related quality of life pre-operatively and at 26 and 52 weeks after ERM surgery	Vision-related quality of life assessed using NEI VFQ-25 quality of life questionnaire	1 year
Secondary	Central retinal thickness pre-operatively and at 26 and 52 weeks after ERM surgery	Central retinal thickness obtained from OCT scans done in clinic	1 year