Lens Implantation, Intraocular
Conditions
Keywords
Pediatric aphakia, Secondary Intraocular Lens Implantation, Glaucoma-related Adverse Events, In-the-bag IOL implantation, Sulcus IOL fixation
Brief summary
To compare the incidence of glaucoma-related adverse events of in-the-bag versus ciliary-sulcus-fixed secondary intraocular lens (IOL) implantation in pediatric aphakia
Detailed description
Treatment of pediatric cataract, one of the leading causes of childhood blindness globally, remains challenging because of extremely high incidence of glaucoma-related adverse events (AEs) after IOL implantation. The investigators aim to compare the incidence of glaucoma-related AEs of in-the-bag versus ciliary-sulcus-fixed secondary intraocular lens (IOL) implantation in pediatric aphakia.
Interventions
PROCEDURESecondary in-the-bag IOL fixation
The experimental group with secondary IOL fixated in the capsular bag
PROCEDURESecondary ciliary sulcus IOL fixation
The control group with secondary IOL fixated in the ciliary sulcus
Sponsors
Zhongshan Ophthalmic Center, Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Months to 14 Years
Healthy volunteers
No
Inclusion criteria
* Aged between 18 months and 14 years * Had a primary diagnosis of congenital cataract. * Underwent cataract extraction between the ages of 2 and 24 months
Exclusion criteria
* Primary IOL implantation * Pre-existing ocular disease which might affect the location and outcome of secondary IOL implantation (including and not restricted to microphthalmia, microcornea, microcornea, corneal opacity, pseudopterygium, iris anomaly, glaucoma diagnosed before cataract extraction, uveitis, persistent fetal vasculature or trauma) * Suture fixation for secondary IOL implantation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of glaucoma-related adverse events | One year after surgery | The assessment of glaucoma-related adverse events is performed at one year after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual acuity | Six months,one year, three years, five years, ten years after surgery | Evaluated with an ETDRS chart. For those who are unable to use ETDRS chart, visual acuity will be evaluated with Lea Symbol Chart or Teller Acuity Cards |
| Ocular refractive power | Six months,one year,three years, five years, ten years after surgery | Measured by the Auto Refractometer |
| Incidence of glaucoma-related adverse events | Six months,three years, five years, ten years after surgery | The assessment of glaucoma-related AEs is performed at six months, three years, five years, ten years after surgery |
| Intraocular lens tilt | Six months,one year, three years, five years, ten years after surgery | Measured by anterior segment scanning |
| Incidence of other adverse events | Six months,one year, three years, five years, ten years after surgery | The assessment of other adverse events will be performed at six months,one year,three years, five years, ten years after surgery |
| Intraocular lens decentration | Six months,one year, three years, five years, ten years after surgery | Measured by anterior segment scanning |
Countries
China
Contacts
Primary ContactZhenzhen Liu, PhD
Outcome results
None listed