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NCT05136950 | Recruiting | Lens Implantation, Intraocular

Incidence of Glaucoma-related Adverse Events in Pediatric Secondary Intraocular Lens Implantation
Sponsor:

Zhongshan Ophthalmic Center, Sun Yat-sen University

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

Condition or disease

Lens Implantation, Intraocular

Intervention/treatment

Secondary in-the-bag IOL fixation

Secondary ciliary sulcus IOL fixation

Phase

Not Applicable

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.}}

Study Type : Interventional
Estimated Enrollment : 228 participants
Masking : Single
Primary Purpose : Treatment
Official Title : Incidence of Glaucoma-related Adverse Events in Pediatric Secondary Intraocular Lens Implantation, In-the-bag Versus Sulcus Fixation : a Randomized Controlled Trial
Actual Study Start Date : December 14, 2021
Estimated Primary Completion Date : July 30, 2023
Estimated Study Completion Date : July 30, 2033
Arm Intervention/treatment

Experimental: Secondary in-the-bag IOL fixation group

In-the-bag IOL fixation is the experimental arm

Procedure: Secondary in-the-bag IOL fixation

Active Comparator: Secondary ciliary sulcus IOL fixation group

Ciliary sulcus IOL fixation is the control arm

Procedure: Secondary ciliary sulcus IOL fixation
Ages Eligible for Study: 18 Months to 14 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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
Incidence of Glaucoma-related Adverse Events in Pediatric Secondary Intraocular Lens Implantation

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Incidence of Glaucoma-related Adverse Events in Pediatric Secondary Intraocular Lens Implantation

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Locations

Recruiting

China,

Zhongshan Ophthalmic Center, Sun Yat-sen University Guangzhou, China, 510060

Guangzhou, China, 510060