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NCT Number: NCT05136950

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

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

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Key information

Conditions

Lens Implantation, Intraocular

Age range

18 month–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Guangzhou, 510060, China

Location status: Recruiting

Location contact

Zhenzhen Liu, PhD

CONTACT

[email protected]

+8613570382241

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Secondary in-the-bag IOL fixation

Procedure

The experimental group with secondary IOL fixated in the capsular bag

Secondary ciliary sulcus IOL fixation

Procedure

The control group with secondary IOL fixated in the ciliary sulcus

Primary outcomes

  1. Incidence of glaucoma-related adverse events

    Time frame: One year after surgery

    The assessment of glaucoma-related adverse events is performed at one year after surgery

Secondary outcomes

  1. Incidence of glaucoma-related adverse events

    Time frame: 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

  2. Visual acuity

    Time frame: 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

  3. Ocular refractive power

    Time frame: Six months,one year,three years, five years, ten years after surgery

    Measured by the Auto Refractometer

  4. Intraocular lens decentration

    Time frame: Six months,one year, three years, five years, ten years after surgery

    Measured by anterior segment scanning

  5. Intraocular lens tilt

    Time frame: Six months,one year, three years, five years, ten years after surgery

    Measured by anterior segment scanning

  6. Incidence of other adverse events

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Zhenzhen Liu, PhD

CONTACT

[email protected]

+86 13570382241

Sponsors and collaborators

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Other

Registry information

Official study title

Incidence of Glaucoma-related Adverse Events in Pediatric Secondary Intraocular Lens Implantation, In-the-bag Versus Sulcus Fixation : a Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2023
Study completion
2033
First posted
Nov 30, 2021
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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