Non-interventional study to obtain real life data from the treatment with Xalatan and Xalacom in Germany and to assess the long-term efficacy and tolerability under routine conditions. Data were entered into an electronic case report form.
Study Type
OBSERVATIONAL
Enrollment
28,812
Change From Baseline in Intraocular Pressure (IOP)
Mean IOP values measured by applanation tonometry. Only Goldman values are displayed; if values were given for both right and left eye, the value of the right eye was analyzed. Change (absolute difference) calculated as mean of (value of IOP at observation minus baseline value). Study course is reported by yearly intervals and clustered as 1 year (12±3 months), 2 years (24±3 months), and 3 years (36±3 months).
Time frame: Baseline, 1 year, 2 years, and 3 years
Aulhorn Stage (Visual Field Defects)
Number of subjects at each Aulhorn stage. Staged as: No scotoma; Stage I (relative scotomas only), Stage II (absolute scotomas without connection to the blind spot), Stage III (absolute scotomas with connection to the blind spot), Stage IV (absolute scotomas more than 1 quadrant affected), and Stage V (temporal residual visual field only). If values were given for both right and left eye, the value of the right eye was analyzed.
Time frame: Baseline, 1 year, 2 years, and 3 years
Change From Baseline in Optic Disc Excavation: Vertical Cup to Disc Ratio
Mean vertical cup to disc (cup/disc or C/D) ratio to assess the progression of glaucoma; calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc). If values were given for both right and left eye, the value of the right eye was analyzed. Change calculated as mean of (value of cup/disc ratio at observation minus baseline value).
Time frame: Baseline, 1 year, 2 years, and 3 years
Change From Baseline in Optic Disc Excavation: Horizontal Cup to Disc Ratio
Mean horizontal cup to disc (cup/disc or C/D) ratio to assess the progression of glaucoma; calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc). If values were given for both right and left eye, the value of the right eye was analyzed. Change calculated as mean of (value of cup/disc ratio at observation minus baseline value).
Time frame: Baseline, 1 year, 2 years, and 3 years
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Investigator Assessment of Xalatan® Efficacy
Number of subjects for Investigator assessment of the efficacy of Xalatan® treatment rated as excellent (highly effective), very good, good, moderate, sufficient, and insufficient (not effective).
Time frame: Baseline, 1 year, 2 years, and 3 years
Subject Assessment of Satisfaction With Xalatan® Treatment
Number of subjects for assessment of subject satisfaction with Xalatan® treatment; categorized as excellent (full satisfaction), very good, good, moderate, sufficient, and insufficient (no satisfaction).
Time frame: Baseline, 1 year, 2 years, and 3 years
Visual Acuity (Visus)
Number of subjects with visual acuity evaluations: amaurosis (partial or total loss of sight); hand movements (able to detect gross object and motion perception without detailed discrimination); finger count (able to count fingers at a given distance); visual acuity scale: range 0.05 (low acuity) to \>1.2 (greater acuity). If values were given for both the right eye and left eye, the value of the right eye was analyzed.
Time frame: Baseline, 1 year, 2 years, and 3 years
Visual Impairment Due to Glaucoma
Number of subjects per level of visual impairment categorized as not at all (no impairment), a little bit, moderate, severe, and very severe (very severe impairment).
Time frame: Baseline, 1 year, 2 years, and 3 years
Subject Self-care: Application of Eye Drops
Number of subjects per level of ability for application (administration) of eye drops categorized as without the help of nursing staff (apply without help) and with the help of nursing staff (apply with help).
Time frame: Baseline, 1 year, 2 years, and 3 years
Reasons for Changes in Glaucoma Therapy
Number of subjects for each reason for change of therapy; there may be more than one reason possible per patient. Reasons for changes in glaucoma therapy was reported from January 2000 through December 2008 independent of the duration of any individual subject's time on study.
Time frame: January 2000 through December 2008
Investigator Assessment of Tolerability of Xalatan® Treatment
Number of subjects for the Investigator's assessment of subjects tolerability of Xalatan® treatment categorized as excellent, very good, good, moderate, sufficient, or insufficient. The occurrence of adverse events (a side effect that may not have any causal relationship to study treatment) was documented as tolerability data.
Time frame: Baseline up to 3 years
Reasons for Discontinuation From Study
Number of subjects per reason for discontinuation from the study. More than one reason for discontinuation is possible per patient. Discontinuation analysis was performed independent of the duration of any individual subject's time on study.
Time frame: January 2000 through December 2008
Changes to the Color of the Iris During Xalatan® or Xalacom® Treatment
Number of subjects with documented change to the color of the iris during treatment with Xalatan® or Xalacom®.
Time frame: Baseline up to 3 years