A total of 764 patients from 28 clinical centers in the United States were enrolled between April 25, 2008, and May 2, 2011, in a prospective observational study of usual LVR care. Participating centers included university-based clinics, private practice settings, and multidisciplinary rehabilitation centers. Appeal for center participation was publicized at professional conferences and research meetings (Envision and the Association for Research in Vision and Ophthalmology) between 2007 and 2010 and by word of mouth. Participation was open to any LVR center in the United States that provided direct care by an optometrist or ophthalmologist and had the ability to comply with the study protocol. The study was approved by The Johns Hopkins University institutional review board and adhered to the tenets of the Declaration of Helsinki. In addition, all the study sites complied with the requirements of the Health Insurance Portability and Accountability Act and, when required, also obtained separate institutional review board approval for their participating centers. All the patients provided oral consent for their study participation before enrollment.
The inclusion criteria were as follows: new patients to LVR (no LVR services from the physician or subspecialty group practice in the past 3 years), age 18 years or older, and ability to hear and respond to questions in English over the telephone. No VA, visual field, or diagnosis requirements were defined because the study objective was to evaluate typical patients seeking LVR services.
Patients were recruited via telephone by each of the 28 sites. A designated individual from each site contacted new patients who had an appointment scheduled 2 weeks or longer after the time of the call. Variation likely existed between centers, and many, but not all, new patients were able to be contacted in advance. After providing verbal agreement to consider participation, each prospective study patient was mailed a contact authorization form in large print that had to be signed and returned in the provided self-addressed stamped envelope to the coordinating center at The Johns Hopkins University before the patient could be contacted. On receipt of the signed contact authorization, a research assistant called the patient, described the study further, and obtained oral consent on the telephone to participate in the study. At that time, either an appointment was scheduled for a future telephone interview or, if the patient was available, the interview began immediately.
The inclusion criteria were as follows: new patients to LVR (no LVR services from the physician or subspecialty group practice in the past 3 years), age 18 years or older, and ability to hear and respond to questions in English over the telephone. No VA, visual field, or diagnosis requirements were defined because the study objective was to evaluate typical patients seeking LVR services.
Patients were recruited via telephone by each of the 28 sites. A designated individual from each site contacted new patients who had an appointment scheduled 2 weeks or longer after the time of the call. Variation likely existed between centers, and many, but not all, new patients were able to be contacted in advance. After providing verbal agreement to consider participation, each prospective study patient was mailed a contact authorization form in large print that had to be signed and returned in the provided self-addressed stamped envelope to the coordinating center at The Johns Hopkins University before the patient could be contacted. On receipt of the signed contact authorization, a research assistant called the patient, described the study further, and obtained oral consent on the telephone to participate in the study. At that time, either an appointment was scheduled for a future telephone interview or, if the patient was available, the interview began immediately.
