Myopia Progression Control Using Atropine 0.05% After Pediatric Cataract Surgery And Intraocular Lens Implantation Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-7
SponsorCairo University

About this trial

Myopic shift remains a debilitating and unpredictable adverse event following pediatric cataract surgery. While research exploring peripheral myopic defocus for post-cataract surgery myopia prevention shows promising results, the use of multifocal intra-ocular lenses (IOLs) cannot be used liberally in countries with high disease burden and challenged economies due to high price and decreased availability. To date there are no studies evaluating the use of topical atropine for the management of myopic shift following pediatric cataract surgery.

The investigators aim to explore the use of 0.05% topical atropine in the prevention and management of myopic shift following pediatric cataract surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Children after IOL implantation (primary or secondary)

Age 1-7 years

Disqualifiers

Eyes with post-operative media opacity hindering adequate assessment of refraction

Eyes with complicated surgeries (e.g. vitreous loss, dropped lens matter requiring PPV, retinal detachment, etc)

Retinal pathologies

Glaucoma (congenital or secondary to surgery)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Atropine Eye drops

    Drug

    Atropine eye drops, 0.05%, will be given following IOL implantation for a period of 12 months.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: AtropineExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in spherical equivalent in diopters of each group.

Spherical equivalent will be determined using auto-refractometer and/or manual retinoscopy. It will be reported in diopters (D).

Time frame
Over a period of 12 months
2

Change in axial length in millimeters in each group.

Axial length will be measured using A-scan or optical biometry and will be reported in millimeters (mm).

Time frame
12 months

Secondary outcomes

1

Rate of side-effects of atropine 0.05% eye drop use.

Rate of side-effects of atropine 0.05 eye drops will be reported as mydriasis leading to photophobia, blurring, and local allergic responses.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: