Investigator led, double-masked, multicenter, randomized clinical trial for the comparison of Atropine 0.5% versus Atropine 0.05% eye drops for the prevention of myopia progression in Dutch children.

Protocol bladzijde 6:
Rationale: With the current worldwide myopia boom the frequency of high myopia
will also increase, and potentially blinding complications such as myopic
macular degeneration, retinal detachment, and glaucoma will occur more often.
In the Netherlands high myopia will become the most important cause of low
vision and blindness by 2050. As treatment options are limited once the eye is
fully grown, prevention of a long axial length at childhood is the only way to
counteract this prospect. Pharmacological interventions have shown a high
efficacy in stopping eye growth, in particular eye drops with high dose
Atropine (0.5%, 1%). Nevertheless, the high frequency of side effects
(photophobia, reading problems) of these Atropine concentrations has favoured
the use of low dose Atropine. Atropine 0.01% is the most commonly used and
lowest dosage; it has shown stability of refractive error, but not of axial
length. Recent studies have shown that Atropine 0.05% has low risk of side
effects, but a higher efficacy than 0.01%. Many ongoing trials are now
comparing various low dose Atropine to placebo, but none are comparing the
highest low dose to the lowest high dose Atropine.

This study has been transitioned to CTIS with ID 2024-516379-34-00 check the CTIS register for the current data.

Objectives:
To compare the efficacy of Atropine 0.05% to Atropine 0.5% treatment in
European children with progressive myopia, and to evaluate the safety,
adherence, and reasons for nonresponse.
To create an online BIG DATA registry for myopia treatment in the Netherlands
which can be used for evaluation of myopia progression in the long term.

Study design: Investigator led, double-masked, multicentre, randomized clinical
trial

Intervention: Comparison of 0.05% Atropine to 0.5% Atropine in a multicentre
study with a 3 year duration, followed by a 2 year observational period.

Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: Prior research with high dose Atropine (0.05%)
revealed a significant slowing of myopia progression in school-age children,
while minimal effects were identified for low dose (0.01%). There is a 50:50
chance for a given child to be randomized to high dose Atropine. There is a
small risk that side effects may occur while using low dose Atropine. For much
higher doses of approved Atropine Sulfate eye drops (1%) used in both North
America & the EU, side effects reported in previous studies of high-dose
Atropine eye drops include: Eye discomfort, glare, blurred near vision, light
sensitivity, pain and stinging at time of drop, inflammation of the cornea
(clear layer on the front of the eye), dry eye, redness and swelling of the eye
or eyelid, irritability, fast heartbeat, restlessness and dryness of skin,
mouth or throat. While the risk of such side effects listed above are much less
for the dilute Atropine (0.01% & 0.5%) eye drops being studied in this
protocol, children may experience other risks or side effects of Atropine eye
drops that are currently unknown. Multifocal photochromic glasses will be
provided to solve blurred near vision and light sensitivity in high dose
Atropine (0.5%).