Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Evolution of best corrected farsight visual acuity (in LogMAR) |
Measurement of the best corrected farsight visual acuity by Early Treatment Diabetic Retinopathy Study type scale (range from -0.3 to 2.6) -0.3 is the best vision and 2.6 the worse |
Month12 |
|
Secondary |
Farsight best corrected visual acuity |
Measurement of the Farsight best corrected visual acuity in LogMAR by Early Treatment Diabetic Retinopathy Study type scale (range from -0.3 to 2.6) -0.3 is the best vision and 2.6 the worse |
Month 3 |
|
Secondary |
Evolution of Farsight best corrected visual acuity |
Measurement of the Farsight best corrected visual acuity in LogMAR by Early Treatment Diabetic Retinopathy Study type scale (range from -0.3 to 2.6) -0.3 is the best vision and 2.6 the worse |
Month 6 |
|
Secondary |
Evolution of Farsight best corrected visual acuity |
Measurement of the Farsight best corrected visual acuity in LogMAR by Early Treatment Diabetic Retinopathy Study type scale (range from -0.3 to 2.6) -0.3 is the best vision and 2.6 the worse |
Month 9 |
|
Secondary |
Evolution of Farsight best corrected visual acuity |
Measurement of the Farsight best corrected visual acuity in LogMAR by Early Treatment Diabetic Retinopathy Study type scale (range from -0.3 to 2.6) -0.3 is the best vision and 2.6 the worse |
Month 15 |
|
Secondary |
Evolution of Farsight best corrected visual acuity |
Measurement of the Farsight best corrected visual acuity by Early Treatment Diabetic Retinopathy Study type scale (range from -0.3 to 2.6) -0.3 is the best vision and 2.6 the worse |
Month 3 |
|
Secondary |
Evolution of Farsight decimal best corrected visual acuity |
Measurement of the Farsight best corrected visual acuity (in LogMAR) measured with a Monoyer scale (range from 20/20 to light perception). 20/20 is the best vision and light perception the worse |
Month 6 |
|
Secondary |
Evolution of Farsight decimal best corrected visual acuity |
Measurement of the Farsight best corrected visual acuity (in LogMAR) measured with a Monoyer scale (range from 20/20 to light perception). 20/20 is the best vision and light perception the worse |
Month 9 |
|
Secondary |
Evolution of Farsight decimal best corrected visual acuity |
Measurement of the Farsight best corrected visual acuity (in LogMAR) measured with a Monoyer scale (range from 20/20 to light perception). 20/20 is the best vision and light perception the worse |
Month 12 |
|
Secondary |
Evolution of Farsight decimal best corrected visual acuity |
Measurement of the Farsight best corrected visual acuity (in LogMAR) measured with a Monoyer scale (range from 20/20 to light perception). 20/20 is the best vision and light perception the worse |
Month 15 |
|
Secondary |
Evolution of Nearsight visual acuity |
Measurement of the best corrected nearsight visual acuity measured using a Parinaud scale (from P48 to P1>.5) P48 is the worse vision and P1.5 the best |
Month 3 |
|
Secondary |
Evolution of Nearsight visual acuity |
Measurement of the best corrected nearsight visual acuity measured using a Parinaud scale (from P48 to P1>.5) P48 is the worse vision and P1.5 the best |
Month 6 |
|
Secondary |
Evolution of Nearsight visual acuity |
Measurement of the best corrected nearsight visual acuity measured using a Parinaud scale (from P48 to P1>.5)P48 is the worse vision and P1.5 the best |
Month 9 |
|
Secondary |
Evolution of Nearsight visual acuity |
Measurement of the best corrected nearsight visual acuity measured using a Parinaud scale (from P48 to P1>.5) P48 is the worse vision and P1.5 the best |
Month 12 |
|
Secondary |
Evolution of Nearsight visual acuity |
Measurement of the best corrected nearsight visual acuity measured using a Parinaud scale (from P48 to P1>.5) P48 is the worse vision and P1.5 the best |
Month 15 |
|
Secondary |
Evolution of retinal nerve fibers layer Optical Coherent Tomography |
physiological parameter : Optical Coherent Tomography |
Month 6 |
|
Secondary |
Evolution of retinal nerve fibers layer Optical Coherent Tomography |
physiological parameter : Optical Coherent Tomography |
Month 12 |
|
Secondary |
automated visual field measurement |
physiological parameter : automated visual field corrected deviation of a visual field, measured according to a protocol STAT protocol 30 (Champ visuel Métrovision, Perenchies, France) |
Month 3 |
|
Secondary |
automated visual field measurement |
physiological parameter : automated visual field |
Month 6 |
|
Secondary |
automated visual field |
physiological parameter : automated visual field corrected deviation of a visual field, measured according to a protocol STAT protocol 30 (Champ visuel Métrovision, Perenchies, France) |
Month 9 of a treatment with BEFIZAL® 200mg (ARROW GENERIQUES) compare to Month 0 |
|
Secondary |
automated visual field measurement |
physiological parameter : automated visual field corrected deviation of a visual field, measured according to a protocol STAT protocol 30 (Champ visuel Métrovision, Perenchies, France) |
Month 12 |
|
Secondary |
automated visual field measurement |
physiological parameter : automated visual field corrected deviation of a visual field, measured according to a protocol STAT protocol 30 (Champ visuel Métrovision, Perenchies, France) |
Month 15 |
|
Secondary |
Manual visual field measurement |
physiological parameter : manual visual field measured with isopters V / 4, III / 1 and II / 1 |
Month 3 |
|
Secondary |
Manual visual field measurement |
physiological parameter : manual visual field measured with isopters V / 4, III / 1 and II / 1 |
Month 6 |
|
Secondary |
Manual visual field measurement |
physiological parameter : manual visual field measured with isopters V / 4, III / 1 and II / 1 |
Month 9 |
|
Secondary |
Manual visual field measurement |
physiological parameter : manual visual field measured with isopters V / 4, III / 1 and II / 1 |
Month 12 |
|
Secondary |
Manual visual field measurement |
physiological parameter : manual visual field measured with isopters V / 4, III / 1 and II / 1 |
Month 15 |
|
Secondary |
National Eye Institute Visual Function Questionnaire 25 |
Questionnaire |
Month 12 |
|
Secondary |
Concentration of serum creatinine |
Concentration of serum creatinine |
Every three months until Month 15 |
|
Secondary |
Concentration of high-density lipoprotein cholesterol |
Blood test |
Every three months until Month 15 |
|
Secondary |
Concentration of very low-density lipoprotein cholesterol |
Blood test |
Every three months until Month 15 |
|
Secondary |
Concentration of triglycerides |
Blood test |
Every three months until Month 15 |
|
Secondary |
Rate of Partial thromboplastin time |
Blood test |
Every three months until Month 15 |
|
Secondary |
Concentration of Aspartate aminotransférase |
Blood test |
Every three months until Month 15 |
|
Secondary |
Concentration of Alanine aminotransférase |
Blood test |
Every three months until Month 15 |
|
Secondary |
Concentration of lactate deshydrogenase |
Blood test |
Every three months until Month 15 |
|
Secondary |
Concentration of creatine kinase |
Blood test |
Every three months until Month 15 |
|