Baseline examination consisted of questionnaires, ophthalmic examination, blood draw, and visual function testing.
Both ways will be employed to ensure the robustness of findings: comparison of visual function in two treatment groups on a continuous scale, and event analysis, where we define a case as progressed if a measurement in visual function test is outside of a 95% confidence interval of the original distribution for this test on two consecutive biannual examinations.
To evaluate if propranolol improves the functional and structural outcome, visual function and ophthalmologic examination are planned at 40 weeks gestational age, 1, 4 122, 18, 18 and 24 months corrected age.
He makes tests of visual function and examines the interior of the eye as part of a general physical examination for symptoms of systemic or neurologic diseases.
Visual function and neurologic examination were normal on discharge.
Main outcome measure Ocular safety (ocular examinations, visual function tests, participants' reports of adverse events, and visual disturbance questionnaire completed by investigators) by treatment group at 12 weeks, 24 weeks, 18 months, and yearly.
During the initial double masked portion of the study, ophthalmologists did ophthalmic examinations and visual function tests in both eyes at baseline and week 12.
In both eyes, we found no clinically significant changes in the results of the ophthalmic examinations and or visual function tests.
The methodological approach included oral administration of questionnaires, medical examinations, laboratory analyses, pulmonary function testing, and measurements of visual function.
The principal finding of both the pivotal trial and its open label extension is that chronic oral sildenafil treatment did not lead to any significant ocular safety signals on ocular examination, on assessment of visual function, or through visual disturbance questionnaires.
