Clinical trial · Interventional
Myopia Progression Control Using Atropine 0.05% After Pediatric Cataract Surgery And Intraocular Lens Implantation Surgery
Myopia Progression Control Using Atropine 0.05% After Pediatric Cataract Surgery And Intraocular Lens Implantation Surgery: A Randomized Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| IOL Implantation | — | UNRESOLVED | — |
| Myopia Progression | — | UNRESOLVED | — |
| Pediatric Cataract | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atropine Eye drops | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Atropine
- description
- Children receiving atropine 0.05% eye drops following IOL implantation. (as intervention)
- interventionNames
- Drug: Atropine Eye drops
- type
- NO_INTERVENTION
- label
- Control
- description
- Children receiving placebo eye drops following IOL implantation.
Primary outcomes (2)
- measure
- Change in spherical equivalent in diopters of each group.
- timeFrame
- Over a period of 12 months
- description
- Spherical equivalent will be determined using auto-refractometer and/or manual retinoscopy. It will be reported in diopters (D).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 7 Years
Show eligibility criteria text
Inclusion criteria: 1. Children after IOL implantation (primary or secondary) 2. Age 1-7 years Exclusion criteria: 1. Eyes with post-operative media opacity hindering adequate assessment of refraction 2. Eyes with complicated surgeries (e.g. vitreous loss, dropped lens matter requiring PPV, retinal detachment, etc) 3. Retinal pathologies 4. Glaucoma (congenital or secondary to surgery) 5. Anterior or posterior segment anomalies
References
Publications (0)
Data not yet available