Age-related macular degeneration (AMD) Eye Diseases Other retinal disorders
Conditions
Interventions
Patients were randomised to:
1. Intervention group: one tablet of Macushield™/MacuHealth with LMZ (dosage: 10 mg L, 10 mg MZ, 2 mg Z) orally, once daily
2. Control group: one tablet of placebo (rice f
Sponsors
Macuvision Europe Limited (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Any race 2. Male or female 3. Aged 18 to 60 years 4. No presence of ocular pathology 5. Visual acuity of at least 6/18 in the study eye
Exclusion criteria
Exclusion criteria: 1. Outside age range 18 to 60 years 2. Pregnancy 3. Presence of ocular pathology
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of retinal sensitivity using microperimetry 2. Serum L and Z (including MZ) concentrations as measured by high-performance liquid chromatography [HPLC] 3. Comparison of MP optical density values measured using the validated gold standard customised HFP device (Densitometer™) to MP optical density values obtained using a MP screening device (MacuScope™) Primary and secondary outcome measures will be carried out at baseline, three, six and nine months. | — |
Primary
| Measure | Time frame |
|---|---|
| MP optical density (including its entire spatial profile), as measured by heterochromatic flicker photometry [HFP]. Primary and secondary outcome measures will be carried out at baseline, three, six and nine months. | — |
Countries
Ireland
Outcome results
None listed