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Glaucoma is one of the leading causes of blindness. Reduction of intraocular pressure is the only proven way to prevent progression of glaucomatous optic neuropathy. The majority of glaucoma patients need to use antiglaucoma ophthalmic solutions over the course of their life. Thus, good adherence and persistency of glaucoma treatment are important factors for better glaucoma care.
The purpose of this study was to investigate the impact of an Internet-based glaucoma care support system on glaucoma medication use.
Patients were randomly divided into two groups. The non–Internet access (NIA) group consisted of patients who had access to the Internet-based glaucoma care support system during the 4-year period only when they were examined by ophthalmologists. The Internet access (IA) group consisted of patients who had the same Internet-based glaucoma care support system access as the NIA group for the first 2 years following enrollment but who were also given free access to the glaucoma care support system for the remaining 2 years. Changes in glaucoma medication use were investigated.
In total, 81 patients in the IA group and 90 patients in the NIA group satisfied the study protocol. The number of antiglaucoma ophthalmic solutions used during the study period significantly increased in the NIA group (
Allowing patients to browse their medical data may reduce the use and improve the effectiveness of glaucoma medication.
UMIN-CTR Clinical Trial Number: UMIN000006982; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000008238&language=E (Archived by WebCite at http://www.webcitation.org/6MRPQeEAv).
Glaucoma is one of the leading causes of acquired blindness and reduction of intraocular pressure (IOP) is the only proven therapy. Glaucoma treatment generally consists of antiglaucoma ophthalmic solutions—medications that are required for long periods of time [
Treatment adherence is a major concern in many chronic diseases [
In recent years, a personalized health record (PHR) system has been proposed. This system uses information and communication technology to allow patients to manage their own health conditions [
Unfortunately, the effects of PHR systems on clinical outcomes in previous studies have not been consistent. Miller et al reported that PHR-enabled self-management did not improve care in multiple sclerosis patients [
Some previous studies have focused on the effects of PHR in glaucoma therapy [
In 2005, we introduced an Internet-based glaucoma care support system (GSS) in Japan. This system allowed glaucoma patients to view their own medical records via the Internet at any time and from any location. The goal of this system was to deepen patient understanding of glaucoma and encourage active involvement in treatment.
In this study, we targeted patients who had used the GSS for more than 4 years and examined how access to the contents of their own glaucoma medical records (“Internet access”) affected their glaucoma treatment.
This randomized, observer-blinded, prospective trial study was performed in accordance with the Helsinki Treaty and was approved by the University of Yamanashi Ethical Review Board. Written informed consent was obtained from all of the patients (see
Flow diagram of study (GSS: glaucoma care support system).
The GSS is a secure online PHR system. Registered patients can use the GSS to view their IOP values, visual field test results, current and prior medications, and other findings from their examination histories related to glaucoma.
The GSS is based on the concept of an information security management system. The data are stored in a database server that is located in a facility at the University of Yamanashi. The registered GSS data are periodically updated by automated medical chart extraction or manual data entry by physicians and medical staff. All the data transferred from medical charts to the GSS are managed offline using locally developed data management programs. Patient registration for the GSS began in 2005, and approximately 1600 glaucoma patients were registered as of November 2011. Our plan was to allow registered patients to access their medical records by themselves. The GSS was the first PHR system routinely used in Japanese clinical ophthalmology care.
First page of GSS. History of medical events are marked on the calendar with numbers explained in a box (arrow). Changes in MD values indicate possibility of deterioration of glaucoma stage. Prescription details are shown by gray or colored bar, respectively. IOP: intraocular pressure, MD: mean deviation, R: right eye, L: left eye.
Results of the static visual field test using the Humphrey visual field test, including gray scale maps, numeric decibels, and the total and pattern deviation. MD: mean deviation, PSD: pattern standard deviation.
The PSD (upper graph) and MD slopes (lower graph) show the possibility of glaucoma progression with a probability analysis. MD: mean deviation, PSD: pattern standard deviation.
Glaucoma patients who had been periodically treated at the University of Yamanashi Hospital Glaucoma Outpatient Clinic and expressed interest in registering with the GSS were subsequently registered for the GSS. Patients were informed of the benefits and risks of the GSS by the ophthalmologist and the medical staff. The patients were also informed that the registered medical records would not be available until security was well established. Registration for the GSS began in 2005. By 2008, only ophthalmologists were allowed to browse the registered medical records, and patients could view their registered medical records in the presence of the attending ophthalmologist at the clinic.
Internet access by patients began in 2008. We randomly selected patients for Internet access between January 2008 and December 2008. The inclusion criteria included the following: patients who had been registered in the GSS database for 2 years and who were diagnosed with either primary open angle glaucoma (POAG), normal tension glaucoma (NTG), or ocular hypertension (OH). The exclusion criteria included the following: patients who were under 20 years old at the time of registration; patients who had a history of intraocular surgery in both eyes; patients for whom accurate IOP measurement was deemed difficult; patients who had received oral glaucoma therapy, such as carbonic anhydrase inhibitors; patients who had a disease other than glaucoma that caused visual field defects; patients with a visual acuity of less than 20/60 or a mean deviation (MD) value lower than –20 dB in the worse eye, as determined by the Humphrey Field Analyzer (HFA) central 30-2 program (Zeiss Inc); and patients diagnosed with dementia whose use of GSS was judged by an ophthalmologist to be difficult.
After re-confirming the patients’ preferences for browsing their registered medical records, identification numbers and temporary passwords were sent to the patients to allow them Internet access. The patients began to browse the GSS after attending lectures by the system staff.
The users were asked to replace their temporary passwords and register their user names with the system. To maintain patient anonymity, no information that could identify a patient—such as name, age, gender, telephone number, home address, or business address—was accessible through the Internet.
The outcomes of the patients who were assigned to the Internet access (IA) group were compared with those of patients who viewed their medical records only with an ophthalmologist during their medical examinations (the non–Internet access group, or NIA group).
Patients who met any of the following criteria were excluded during the 2-year period post Internet access: those who died; had glaucoma surgery, including laser treatment; received oral glaucoma therapy, such as carbonic anhydrase inhibitors; developed a disease other than glaucoma that caused visual field disturbances or IOP changes; and developed severe visual impairment or dementia that caused GSS use to become difficult as judged by an ophthalmologist.
All of the patients visited the Glaucoma Outpatient Clinic at the University of Yamanashi Hospital approximately every 3 months. A best-corrected visual acuity (BCVA) measurement, an IOP measurement using a Goldmann applanation tonometer, a slit-lamp examination, and a fundus examination were performed as part of the routine examinations. The HFA visual field test was usually performed every 6-10 months and disc photography was performed every year. No differences were found in the ophthalmological examination protocol or follow-up schedule between the NIA and IA groups. The patient and the attending ophthalmologist discussed the results of the glaucoma examination using data displayed by the GSS. The ophthalmologists did not know whether the patient browsed the GSS data at home or elsewhere.
Any glaucoma medication changes were determined by glaucoma specialists with the patient’s consent. The medical glaucoma treatment was determined by glaucoma specialists using a targeted IOP strategy. The specialists increased the number of glaucoma medication treatments in response to the following test results: two or more consecutive IOP values exceeding the target IOP, glaucomatous neuropathy deterioration suggested by a visual field test, and imaging tests focused on the optic nerve head and nerve fiber layer thickness. If two or more consecutive IOP values were sufficiently below the target IOP and the glaucoma specialists judged that reducing the glaucoma medication would not elevate the IOP over the target value, the glaucoma medication was reduced.
This study compared the amount of antiglaucoma ophthalmic solution used, MD values, and BCVA values between the two groups. In addition, we performed a subanalysis of IOP changes over the study period in those patients who did not report any changes in the amount of antiglaucoma ophthalmic solution used during the study. The IOP profiles were compared in the NIA and IA groups. IOP changes from the pre-IA to the post-IA period were also compared in the IA groups. The right eye was chosen for the analysis. If the right eye met exclusion criteria, then the left eye was subject to the analysis.
We analyzed changes in the amount of antiglaucoma ophthalmic solution used for individual patients and individual eyes. If the change in the amount of antiglaucoma ophthalmic solution used during the study period differed between the right and left eyes, the eye that showed greater change was used in the analysis. Any change in the concentration of the antiglaucoma ophthalmic solution used was considered to be a change in the antiglaucoma medication. However, a change to a different antiglaucoma ophthalmic solution having the same pharmacological action and similar IOP-reducing potential was not considered to be a change. For example, changing from a latanoprost ophthalmic solution to another prostaglandin-related antiophthalmic solution (other than an isopropyl unoprostone solution) and changing from a timolol maleate ophthalmic solution to another beta-blocker ophthalmic solution were not considered to be changes in antiglaucoma medication.
We investigated the change in medication possession ratio (MPR) among patients whose medication was not changed through the study period. A useful definition of MPR as a parameter to measure adherence is the ratio of the days of prescription supply dispensed over the number of days between the first and last prescription refill [
The data were analyzed using the JMP 8.0 software package (SAS Institute Inc), and the values are presented as the mean and standard deviation (SD). Changes in the amount of antiglaucoma ophthalmic solutions used were analyzed using the Wilcoxon signed rank test or a contingency table analysis. The IOP, BCVA (expressed as logMAR), MD values of the HFA central 30-2 program, and MPR were compared between the IA and NIA groups using the Mann-Whitney U test. The IOP changes within a group were analyzed using the Student
In total, 194 patients were randomly assigned to the two groups, and 81 IA and 90 NIA patients completed the study.
Characteristics of all enrolled patients.
Group | Start of IA | Details of dropout during the IA period | |||||
Patients, n | Age, years |
Male, % | PEa | TLEb | Oral CAIc | Change in address | |
IA (Internet access) | 88 | 62.6 (15.1) | 62.6 | 2 | 2 | 1 | 2 |
NIA (non−Internet access) | 96 | 64.6 (12.5) | 87.1 | 1 | 2 | 2 | 1 |
aPE: phacoemulcification.
bTLE: trabeculectomy.
cCAI: carbonic anhydrase inhibitor.
Characteristics of completed patients (numbers in parentheses are standard deviation).
Group | Patients, n | Age, years |
Type of glaucomaa (POAG:NTG:OH) | Male (%) | Initial BCVAb | Final BCVA | Initial MDc (dB) | Final MD (dB) |
IA (Internet Access) | 81 | 61.8 (15.3) | 36:42:3 | 63.0 | 0.09 (0.39) | 0.1 (0.39) | –6.47 (7.36) | –7.16 (7.66) |
NIA (Non−Internet Access) | 90 | 63.4 (11.8) | 38:47:5 | 54.4 | 0.03 (0.22) | 0.03 (0.22) | –6.27 (7.36) | –6.83 (7.43) |
aPOAG: primary open angle glaucoma, NTG: normal tension glaucoma, OH: ocular hypertension.
bBCVA: best-corrected visual acuity.
cMD: mean deviation.
The number of antiglaucoma ophthalmic solutions used at the initial examination in the IA group was mean 1.2 (SD 1.2) in the right eye and mean 1.3 (SD 1.1) in the left eye, while the same number in the NIA group was mean 1.0 (SD 1.0) in the right eye and mean 1.1 (SD 1.0) in the left eye. The number of antiglaucoma ophthalmic solutions used did not differ significantly between the IA and NIA groups. In the NIA group at the final examination, it was mean 1.2 (SD 1.1) in the right eye and mean 1.2 (SD 1.0) in the left eye, which were significantly greater than the values at the initial examination (
Changes in glaucoma medication during the study period (*
IOP values at the first examination of the IA and NIA groups were mean 15.3 (SD 4.2) mmHg and mean 15.1 (SD 3.1) mmHg, respectively (
We examined the patients whose antiglaucoma ophthalmic solution use did not change over the course of the study. The subjects included 46 patients in the IA group and 55 patients in the NIA group. The distribution of the cases is shown in
Characteristics of patients whose antiglaucoma ophthalmic solution use did not change during the study period (numbers in parentheses are standard deviation).
Group | Patients, n | Age, years |
Type of glaucomaa (POAG:NTG:OH) | Male, % | # of antiglaucoma ophthalmic solution | Initial BCVAb | Final BCVA | Initial MDc (dB) | Final MD (dB) |
IA (Internet Access) | 46 | 63.7 (12.8) | 21:24:1 | 66.7 | 1.5 (0.9) | 0.08 (0.38) | 0.10 (0.40) | –6.01 (7.32) | –7.04 (7.61) |
NIA (Non−Internet Access) | 55 | 66.4 (10.7) | 21:32:2 | 61.1 | 1.2 (0.8) | 0.09 (0.31) | 0.10 (0.25) | –6.67 (7.24) | –8.07 (7.94) |
aPOAG: primary open angle glaucoma, NTG: normal tension glaucoma, OH: ocular hypertension.
bBCVA: best-corrected visual acuity.
cMD: mean deviation.
The IOP values in the IA and NIA groups were mean 15.2 (SD 4.2) mmHg and mean 14.5 (SD 2.1) mmHg at the first examination, respectively. No significant IOP differences were observed between the IA and NIA groups (
Differences in the IOP values between the first examination and the final examination in the IA group and NIA group were mean 0.2 (SD 1.4) mmHg (
In the IA group, the IOP of both eyes changed significantly between the pre-IA period and the post-IA period.
A change in the intraocular pressure at 24 months after the start of the study was defined as zero mmHg. IA: Internet access group, NIA: non-Internet access group.
In the IA group, the MPRs before and after the start of Internet access were mean 82.3% (SD 30.7) and 91.1% (SD 40.3), respectively, which indicates a significant improvement (
The utility of patient education and medical information services has been previously discussed [
It was common for the patients to increase their medication use during the treatment period. Indeed, 17.8% (16/90) of the NIA patients increased their glaucoma medications during the study period, while only 8.6% (7/81) of the IA patients did. In addition, 13.6% (11/81) of the IA patients reduced their medications during the study period. Notably, among the patients whose antiglaucoma ophthalmic solution use did not change during the study period, the Internet access group shifted from an increasing IOP trend to a decreasing trend. It is possible that the amount of antiglaucoma ophthalmic solutions used was increased in the patients who did not start Internet access. It is unclear whether the current outcomes were the direct results of Internet access or were due to other mechanisms, such as improved patient-physician communication during office visits. Improving adherence may contribute to these outcomes, although we were unable to monitor changes in adherence using subjective and quantitative methods, such as electronic monitoring systems, which are not available in Japan.
The current study showed that Internet access significantly improved the MPR among patients whose medication was not changed during the study and that Internet access may contribute to a reduction in IOP over time. The MPR in the current study is higher than that in Friedman’s report [
Health literacy is an important consideration in using electronic PHRs appropriately. We examined glaucoma literacy by administering a questionnaire to another set of patients who had been registered with the GSS for more than 2 years [
Although the current study demonstrated the effects of Internet access on glaucoma treatment, these effects are not consistent with those observed in previous studies. In their review, Tenforde et al [
We used a prospective, randomized study design, but the NIA patients were slightly older than the IA patients. The effect of age on adherence is controversial. Dietlein et al have reported that adherence to therapy with antiglaucoma ophthalmic solutions deteriorated with age [
Comparison of the rates of glaucoma patients’ understanding of their target intraocular pressure (*
Comparison of number of correct answers to questions regarding glaucoma (*
The patients in this study were GSS users. Given that many patients cannot use a personal computer or the Internet due to their age, poverty, or other reasons, it is possible that the patients in this study are not representative of general glaucoma patients. The present study did not examine how frequently the patients accessed the GSS. Therefore, further investigations should be performed to verify the relationship between the frequency of use and the improvements in glaucoma treatment associated with using the system.
The current study confirmed that patients’ understanding of their glaucoma care status may play an important role in better management.
CONSORT-EHEALTH Checklist V1.6.2 [
Days of supplied medication for antiglaucoma ophthalmic solutions used.
Antiglaucoma ophthalmic solutions used (1).
Antiglaucoma ophthalmic solutions used (2).
analysis of covariance
best-corrected visual acuity
carbonic anhydrase inhibitor
glaucoma care support system
Humphrey Field Analyzer
Internet access
intraocular pressure
mean deviation
medication possession ratio
non–Internet access
normal tension glaucoma
ocular hypertension
phacoemulcification
personalized health record
primary open angle glaucoma
trabeculectomy
The authors thank Ms Kazumi Okudaira and Ms Kunie Ishihara who contributed greatly to the operation and management of the GSS. The authors are grateful to Dr Harmish Fraser for manuscript editing.
None declared.