M Charts Versus Amsler Test in Evaluating Metamorphopsia in nAMD

NCT05324150 | Completed DMC

• 1 other identifier: Metamorphopsia_01
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

Age-related macular degeneration (AMD) is a complex eye disorder and the most common macular disease affecting millions of aged people in the developed countries, with an estimation that the number of AMD patients will be increased to 196 million in 2020, 288 million in 2040. Vision loss, central scotomas and metamorphopsia are the hallmark signs in patients with macular diseases. Metamorphopsia can be defined as a deformation of seen rectilinear lines due to photoreceptor separation/location and it is a typical but not exclusive sign of retinal disease. The most effective method of treating wet AMD is currently the anti-vascular endothelial growth factor intravitreal injections (anti-VEGF). A further concern is the enormous costs and restriction of human resources that make periodic imaging unfeasible. Therefore, in patients with AMD treated by intravitreal anti-VEGF, monitoring with sensitive psychophysical tools could advance the time for diagnosis of CNV reactivation and enhance the outcome of treatment. For assessment of the visual function, visual acuity and Amsler grid have been the gold standard. The Amsler grid is a simple and noninvasive test effortlessly understood by the patient, consisting of evenly spaced vertical and horizontal lines outlining 400 square, it has been widely adopted as a subjective test for metamorphopsia. However, it also produces high false-negative rate. Moreover, the answer to this test is dichotomous: straight or crooked lines and does not allow for quantification thus, it is problematic to monitor the visual function along the course and to evaluate the effectiveness of treatment with anti-VEGF agents. The M-chart (Inami Co., Tokyo, Japan) is a diagnostic device developed by Matsumoto to quantify the grade of metamorphopsia in patients with various types of macular diseases. The usefulness of M-charts has been already demonstrated in different retinal diseases from macular pucker to BRVO. The aim of this study is to compare the traditional Amsler grid and the M-Charts in evaluating metamorphopsia in patients suffering from wet AMD before and after Anti VEGF injection; and to match it with OCT results.

Conditions

Macular Degeneration, Wet; Metamorphopsia

Keywords

Macular Degeneration Wet; nAMD; Metamorphopsia; Anti-VEGF Intravitreal Injections; Amsler Test; M Charts

Outcome Measures

Primary Outcomes (3)

• Change in VM

  Change in values of Vertical M Charts ( from 0 to 2.0 )

  baseline and after 1, 3, 6, 12 months ( 5 measurements)

• Change in HM

  Change in values of Horizontal M Charts ( from 0 to 2.0)

  baseline and after 1, 3, 6, 12 months ( 5 measurements)

• Change in Amsler Test

  Change in values of this test: Positivity (+) or negativity (-)

  baseline and after 1, 3, 6, 12 months ( 5 measurements)

Secondary Outcomes (2)

• CRT

  baseline, after 1, 3, 6, 12 months

• Visual Acuity

  baseline, after 1, 3, 6, 12 months

Other Outcomes (1)

• OCT morphological parameters

  baseline, after 1, 3, 6, 12 months

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Case only study: heterogeneous group of patients diagnosed with active maculopathy

You may qualify if:

• Diagnosis of neovascular age-related macular degeneration with active CNV on fluorangiographic examination
• Visual acuity (VA) equal to or greater than 1.0 logMAR
• Written informed consent
• Age over 50.

You may not qualify if:

• Prior intravitreal injection or intraocular surgery
• Major ocular diseases such as amblyopia, glaucoma, or strabismus, and refracting errors greater than 4D.

Sponsors & Collaborators

• Ospedale Santa Croce-Carle Cuneo: lead

Study Sites (1)

Ospedale Santa Croce

Cuneo, Piedmont, 12100, Italy

Location

Related Publications (9)

• Wong WL, Su X, Li X, Cheung CM, Klein R, Cheng CY, Wong TY. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health. 2014 Feb;2(2):e106-16. doi: 10.1016/S2214-109X(13)70145-1. Epub 2014 Jan 3.

  PMID: 25104651 BACKGROUND

• Simunovic MP. METAMORPHOPSIA AND ITS QUANTIFICATION. Retina. 2015 Jul;35(7):1285-91. doi: 10.1097/IAE.0000000000000581.

  PMID: 26049620 BACKGROUND

• Campa C, Parodi MB. Anti-Vegf Therapy for Ocular Diseases: Present and Future. Curr Drug Targets. 2020;21(12):1158. doi: 10.2174/138945012112200727153907. No abstract available.

  PMID: 32957867 BACKGROUND

• Musa F, Muen WJ, Hancock R, Clark D. Adverse effects of fluorescein angiography in hypertensive and elderly patients. Acta Ophthalmol Scand. 2006 Dec;84(6):740-2. doi: 10.1111/j.1600-0420.2006.00728.x.

  PMID: 17083530 BACKGROUND

• Loewenstein A, Malach R, Goldstein M, Leibovitch I, Barak A, Baruch E, Alster Y, Rafaeli O, Avni I, Yassur Y. Replacing the Amsler grid: a new method for monitoring patients with age-related macular degeneration. Ophthalmology. 2003 May;110(5):966-70. doi: 10.1016/S0161-6420(03)00074-5.

  PMID: 12750099 BACKGROUND

• Wada I, Yoshida S, Kobayashi Y, Zhou Y, Ishikawa K, Nakao S, Hisatomi T, Ikeda Y, Ishibashi T, Sonoda KH. Quantifying metamorphopsia with M-CHARTS in patients with idiopathic macular hole. Clin Ophthalmol. 2017 Sep 20;11:1719-1726. doi: 10.2147/OPTH.S144981. eCollection 2017.

  PMID: 29033537 BACKGROUND

• Nowomiejska K, Oleszczuk A, Brzozowska A, Grzybowski A, Ksiazek K, Maciejewski R, Ksiazek P, Juenemann A, Rejdak R. M-charts as a tool for quantifying metamorphopsia in age-related macular degeneration treated with the bevacizumab injections. BMC Ophthalmol. 2013 Apr 15;13:13. doi: 10.1186/1471-2415-13-13.

  PMID: 23587218 BACKGROUND

• Querques G, Querques L, Rafaeli O, Canoui-Poitrine F, Bandello F, Souied EH. Preferential hyperacuity perimeter as a functional tool for monitoring exudative age-related macular degeneration in patients treated by intravitreal ranibizumab. Invest Ophthalmol Vis Sci. 2011 Sep 1;52(9):7012-8. doi: 10.1167/iovs.11-7517.

  PMID: 21885622 BACKGROUND

• Schuchard RA. Validity and interpretation of Amsler grid reports. Arch Ophthalmol. 1993 Jun;111(6):776-80. doi: 10.1001/archopht.1993.01090060064024.

  PMID: 8512478 BACKGROUND

MeSH Terms

Conditions

Wet Macular Degeneration; Vision Disorders

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Silvia Violante, MD

  OSCroceCarle, +39 0171 641571

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator

Study Record Dates

• First Submitted: March 27, 2022
• First Posted: April 12, 2022
• Study Start: May 9, 2022
• Primary Completion: June 30, 2023
• Study Completion: September 30, 2023
• Last Updated: November 2, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)