Reading Speed Improvements in Wet-AMD Patients After Ranibizumab Treatment

NCT04982484 | Completed

• 1 other identifier: 2010-01-UPMS
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

AMD (age-related macular degeneration), is the leading cause of blindness in individuals over the age of 55. There is no cure for wet-AMD but anti-VEGF treatments significantly minimize the vision loss over time. To study the correlation between anti-VEGF injection bevacizumab (Lucentis), visual acuity, macular thickness and last but not least reading speed in wet-AMD patients. The study was conducted on 50 eyes of 50 wet-AMD patients. Subjects were monthly treated with an intra-vitreal Lucentis injection for 3 months; further injections were given when a loss of 5 or more letters of visual acuity was observed and/or when the retinal thickness in the affected macular area increased by 100 µm. In addition to a full ophthalmological examination reading speed was investigated via the Radner reading chart before and 3 months after treatment. The collected data was analyzed using paired t-tests.

Conditions

Ophthalmopathy; Wet Macular Degeneration

Outcome Measures

Primary Outcomes (2)

• Reading speed day 0

  Reading speed measurement via Radner reading chart (a highly standardized multilingual reading test system that was developed for clinical practice and research) We measured reading speed on 50 patients before and 3 months after treatment. The reading chart consists of "sentence optotypes", which are optimized reading test items, standardized by construction and statistical selection. Sentence optotypes consist of short sentences that are highly comparable in terms of number of words (14 words), word length, and position of words, lexical difficulty and syntactical complexity. Language specific characteristics were taken into account as were the number of letters and syllables per word, line, and sentence. The advantage of such sentence optotypes is that they minimize variations between test items and keep the geometric proportions constant.

  day 0

• Reading speed M3

  Reading speed measurement via Radner reading chart (a highly standardized multilingual reading test system that was developed for clinical practice and research) We measured reading speed on 50 patients before and 3 months after treatment. The reading chart consists of "sentence optotypes", which are optimized reading test items, standardized by construction and statistical selection. Sentence optotypes consist of short sentences that are highly comparable in terms of number of words (14 words), word length, and position of words, lexical difficulty and syntactical complexity. Language specific characteristics were taken into account as were the number of letters and syllables per word, line, and sentence. The advantage of such sentence optotypes is that they minimize variations between test items and keep the geometric proportions constant.

  month 3

Secondary Outcomes (4)

• Visual acuity using the ETDRS chart day 0

  day 0

• Visual acuity using the ETDRS chartM3

  month 3

• Maculare thickness Day0

  day 0

• Maculare thickness M3

  Month 3

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Macular oedema due to WET-AMD

You may qualify if:

• AMD, Age related macular degeneration (Wet-form)

You may not qualify if:

• Age related macular degeneration (Dry-form)
• Diabetic macular oedema
• Other related macular oedemas

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead
• University of Pecs: collaborator

MeSH Terms

Conditions

Eye Diseases; Wet Macular Degeneration

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases

Study Officials

• Georges Jr Hayek, MD

  CHR Metz Thionville Hopital de Mercy

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: July 29, 2021
• Study Start: September 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: August 1, 2013
• Last Updated: July 29, 2021

Record last verified: 2021-07