A phone call guided visual acuity self assessment in AMD patients -prognostic value of standardized tests and comparison of recent usual care versus phone call-based screening strategy for maintaining the vision gain after Ranibizumab injections

• Conditions: age-related macular degeneration; H35.3; Degeneration of macula and posterior pole

• Registration Number: DRKS00000768
• Lead Sponsor: niversitätsklinikum Leipzig AöRKlinik und Poliklinik für Augenheilkunde,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-18
• Study Completion: 2013-06-11
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

1. wet age-related macular degeneration, pretreated or untreated,
2. Visual acuity 69-24 ETDRS-letters at least one eye
3. Age> 60 years
4. written consent for study participation of the patient
5. Upload indication for treatment (3 injections with ranibizumab) or for maintenance therapy in previously treated patients with Ranibizumab
6. Patient has a technical (telephone) and other conditions for carrying out the study procedures
7. regular visits at the clinic is possible

Exclusion Criteria

1. Patients with active ocular or periocular infection or suspected to
2. Patients with severe intraocular inflammation
3. previous photodynamic therapy
4. uncontrolled glaucoma, uveitis, advanced cataract
5. State after filtration surgery, status post retinal surgery, status post intraocular surgery in less than 3 months
6. known allergy to ranibizumab
7. physically, mentally or otherwise induced inability to provide information requested (eg questionnaire: because of dementia, language difficulties, ...) or to participate in the tests required
8. Participation in other interventional therapy studies
9. lack of cooperation (compliance)
10. not permitted concomitant therapies

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reliability and validity of telephone-assisted visual acuity self-test of patient by ACTO and Amsler procedures compared to clinical diagnosis cascade (ETDRS, funduscopy, OCT, possibly photography of the fundus and FAG)<br>

Secondary Outcome Measures

Name	Time	Method
further aspects of reliability of the telephone screening:<br> • test-retest reliability;<br> • inter-rater reliability;<br>acquisition of the quality of life for vision by NEI (patient self-report) questionnaires<br>