Smartphone enabled device for remote ophthalmological evaluation

The ocular diagnosis is (largely) based on visual inspection. Hence, by
visually inspecting ophthalmic images or video*s, an ophthalmologist may be
able to remotely make a proper ophthalmic diagnosis, aptly named
teleopthalmology. Additionally, the eye pressure is regularly determined in the
clinical setting, which can also potentially be done remotely (via non-contact
tonometry).
We have therefore developed the smartphone enabled device. With this
tool attached to a smartphone, a patient him/herself (or a relative) can easily
make a slit-image or video of the anterior part of the eye. For an eye pressure
determination the patient can also make a video, but now while the device
directs an air puff at the cornea. The ophthalmologist can then remotely
inspect the image and/or video and act/advice accordingly.
However, in order to evaluate ease of use both for the patient and the
ophthalmologist, and to establish its diagnostic sensitivity and specificity as
compared to in-clinic diagnostics, clinical trials must be performed.
We believe that remote eye diagnosis with the device will improve
(cost) efficacy of ophthalmic services, facilitate timely referrals and
increase patient safety.

Study part 1

A) To determine specificity and sensitivity of diagnosis of anterior ocular
pathology with the smartphone enabled device, as compared to in-clinic
slit-lamp and tonometry examination (gold standard).
B) To determine ease of use of the device over a short (days) period of time.

Study part 2

A) To determine whether specificity and sensitivity of the device in predicting
necessary emergency visits during a short post-surgery is better than
phone calls only, as determined afterwards by in-clinic examination
(gold standard).

Part 1: crossover trial (and short-term beta test).
Part 2: controlled trial.

During the trial the smartphone enabled device will be used for diagnostics.

Patients will have to use the smartphone enabled device, which is a slight time
burden (about an hour total). Risks are minimal, as regular clinic visits
continue during the study.