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

NCT05136950 | Recruiting

• 1 other identifier: 2021KYPJ135
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

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

Conditions

Lens Implantation, Intraocular

Keywords

Pediatric aphakia; Secondary Intraocular Lens Implantation; Glaucoma-related Adverse Events; In-the-bag IOL implantation; Sulcus IOL fixation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Incidence of glaucoma-related adverse events

  Six months,three years, five years, ten years after surgery

• Visual acuity

  Six months,one year, three years, five years, ten years after surgery

• Ocular refractive power

  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

• Intraocular lens tilt

  Six months,one year, three years, five years, ten years after surgery

Study Arms (2)

Secondary in-the-bag IOL fixation group

EXPERIMENTAL

In-the-bag IOL fixation is the experimental arm

Procedure: Secondary in-the-bag IOL fixation

Secondary ciliary sulcus IOL fixation group

ACTIVE COMPARATOR

Ciliary sulcus IOL fixation is the control arm

Procedure: Secondary ciliary sulcus IOL fixation

Interventions

Secondary in-the-bag IOL fixation PROCEDURE

The experimental group with secondary IOL fixated in the capsular bag

Secondary in-the-bag IOL fixation group

Secondary ciliary sulcus IOL fixation PROCEDURE

The control group with secondary IOL fixated in the ciliary sulcus

Secondary ciliary sulcus IOL fixation group

Eligibility Criteria

• Age: 18 Months - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (1)

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

Guangzhou, 510060, China

RECRUITING

Related Publications (7)

• 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 J Ophthalmol. 2022 Apr;236:183-192. doi: 10.1016/j.ajo.2021.10.006. Epub 2021 Oct 13.

  PMID: 34653355 RESULT

• 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.

  PMID: 27367747 RESULT

• 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 Randomized Clinical Trial. JAMA Ophthalmol. 2021 Feb 1;139(2):165-173. doi: 10.1001/jamaophthalmol.2020.5664.

  PMID: 33331850 RESULT

• 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.

  PMID: 25579641 RESULT

• 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. doi: 10.1371/journal.pone.0172979. eCollection 2017.

  PMID: 28301497 RESULT

• 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.

  PMID: 25325868 RESULT

• Zou Y, Jin L, Qu B, Chen H, Zeng M, Li X, Liu X, Luo L, Liu Z, Liu Y. Safety and efficacy in pediatric secondary intraocular lens implantation, in-the-bag versus sulcus implantation: a multicenter, single-blinded randomized controlled trial. Trials. 2023 Jun 9;24(1):388. doi: 10.1186/s13063-023-07411-z.

  PMID: 37296411 DERIVED

Study Officials

• Yizhi Liu, PhD

  Zhongshan Ophthalmic center, Guangzhou, People's Republic of China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenzhen Liu, PhD

CONTACT

+86 13570382241; liu_zhenzhen@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 30, 2021
• Study Start: December 14, 2021
• Primary Completion: July 30, 2023
• Study Completion (Estimated): July 30, 2033
• Last Updated: January 11, 2022

Record last verified: 2022-01

Locations

CN (1)