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

Lens Implantation, Intraocular Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05136950
• Other study ID #: 2021KYPJ135
• Status: Recruiting
• Phase: N/A
• Start date: December 14, 2021
• Est. completion date: July 30, 2033

Study information

• Verified date: January 2022
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: Zhenzhen Liu, PhD
• Phone: +86 13570382241
• Email: liu_zhenzhen[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 228
• Est. completion date: July 30, 2033
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Lens Implantation, Intraocular

Intervention

Procedure:
• Secondary in-the-bag IOL fixation
The experimental group with secondary IOL fixated in the capsular bag
• Secondary ciliary sulcus IOL fixation
The control group with secondary IOL fixated in the ciliary sulcus

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen University Guangzhou, China, 510060	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (6)

Freedman SF, Beck AD, Nizam A, Vanderveen DK, Plager DA, Morrison DG, Drews-Botsch CD, Lambert SR; Infant Aphakia Treatment Study Group. Glaucoma-Related Adverse Events at 10 Years in the Infant Aphakia Treatment Study: A Secondary Analysis of a Randomize — View Citation

Liu Z, Lin H, Jin G, Tan X, Qu B, Jin L, Chen X, Wang W, Han X, Xu J, Ying G, Han Y, He M, Congdon N, Chen W, Luo L, Liu Y. In-the-Bag Versus Ciliary Sulcus Secondary Intraocular Lens Implantation for Pediatric Aphakia: A Prospective Comparative Study. Am — View Citation

Shenoy BH, Mittal V, Gupta A, Sachdeva V, Kekunnaya R. Complications and visual outcomes after secondary intraocular lens implantation in children. Am J Ophthalmol. 2015 Apr;159(4):720-6. doi: 10.1016/j.ajo.2015.01.002. Epub 2015 Jan 9. — View Citation

Whitman MC, Vanderveen DK. Complications of pediatric cataract surgery. Semin Ophthalmol. 2014 Sep-Nov;29(5-6):414-20. doi: 10.3109/08820538.2014.959192. Review. — View Citation

Wood KS, Tadros D, Trivedi RH, Wilson ME. Secondary intraocular lens implantation following infantile cataract surgery: intraoperative indications, postoperative outcomes. Eye (Lond). 2016 Sep;30(9):1182-6. doi: 10.1038/eye.2016.131. Epub 2016 Jul 1. — View Citation

Zhao YE, Gong XH, Zhu XN, Li HM, Tu MJ, Coursey TG, Pflugfelder SC, Gu F, Chen D. Long-term outcomes of ciliary sulcus versus capsular bag fixation of intraocular lenses in children: An ultrasound biomicroscopy study. PLoS One. 2017 Mar 16;12(3):e0172979. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of glaucoma-related adverse events	The assessment of glaucoma-related adverse events is performed at one year after surgery	One year after surgery
Secondary	Incidence of glaucoma-related adverse events	The assessment of glaucoma-related AEs is performed at six months, three years, five years, ten years after surgery	Six months,three years, five years, ten years after surgery
Secondary	Visual acuity	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	Six months,one year, three years, five years, ten years after surgery
Secondary	Ocular refractive power	Measured by the Auto Refractometer	Six months,one year,three years, five years, ten years after surgery
Secondary	Intraocular lens decentration	Measured by anterior segment scanning	Six months,one year, three years, five years, ten years after surgery
Secondary	Intraocular lens tilt	Measured by anterior segment scanning	Six months,one year, three years, five years, ten years after surgery
Secondary	Incidence of other adverse events	The assessment of other adverse events will be performed at six months,one year,three years, five years, ten years after surgery	Six months,one year, three years, five years, ten years after surgery