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

Primary Purpose

Lens Implantation, Intraocular

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Secondary in-the-bag IOL fixation
Secondary ciliary sulcus IOL fixation
Sponsored by
Zhongshan Ophthalmic Center, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lens Implantation, Intraocular focused on measuring Pediatric aphakia, Secondary Intraocular Lens Implantation, Glaucoma-related Adverse Events, In-the-bag IOL implantation, Sulcus IOL fixation

Eligibility Criteria

18 Months - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Secondary in-the-bag IOL fixation group

Secondary ciliary sulcus IOL fixation group

Arm Description

In-the-bag IOL fixation is the experimental arm

Ciliary sulcus IOL fixation is the control arm

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
Ocular refractive power
Measured by the Auto Refractometer
Intraocular lens decentration
Measured by anterior segment scanning
Intraocular lens tilt
Measured by anterior segment scanning
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

Full Information

First Posted
November 1, 2021
Last Updated
January 6, 2022
Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT05136950
Brief Title
Incidence of Glaucoma-related Adverse Events in Pediatric Secondary Intraocular Lens Implantation
Official Title
Incidence of Glaucoma-related Adverse Events in Pediatric Secondary Intraocular Lens Implantation, In-the-bag Versus Sulcus Fixation : a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2021 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
July 30, 2033 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lens Implantation, Intraocular
Keywords
Pediatric aphakia, Secondary Intraocular Lens Implantation, Glaucoma-related Adverse Events, In-the-bag IOL implantation, Sulcus IOL fixation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
228 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Secondary in-the-bag IOL fixation group
Arm Type
Experimental
Arm Description
In-the-bag IOL fixation is the experimental arm
Arm Title
Secondary ciliary sulcus IOL fixation group
Arm Type
Active Comparator
Arm Description
Ciliary sulcus IOL fixation is the control arm
Intervention Type
Procedure
Intervention Name(s)
Secondary in-the-bag IOL fixation
Intervention Description
The experimental group with secondary IOL fixated in the capsular bag
Intervention Type
Procedure
Intervention Name(s)
Secondary ciliary sulcus IOL fixation
Intervention Description
The control group with secondary IOL fixated in the ciliary sulcus
Primary Outcome Measure Information:
Title
Incidence of glaucoma-related adverse events
Description
The assessment of glaucoma-related adverse events is performed at one year after surgery
Time Frame
One year after surgery
Secondary Outcome Measure Information:
Title
Incidence of glaucoma-related adverse events
Description
The assessment of glaucoma-related AEs is performed at six months, three years, five years, ten years after surgery
Time Frame
Six months,three years, five years, ten years after surgery
Title
Visual acuity
Description
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
Time Frame
Six months,one year, three years, five years, ten years after surgery
Title
Ocular refractive power
Description
Measured by the Auto Refractometer
Time Frame
Six months,one year,three years, five years, ten years after surgery
Title
Intraocular lens decentration
Description
Measured by anterior segment scanning
Time Frame
Six months,one year, three years, five years, ten years after surgery
Title
Intraocular lens tilt
Description
Measured by anterior segment scanning
Time Frame
Six months,one year, three years, five years, ten years after surgery
Title
Incidence of other adverse events
Description
The assessment of other adverse events will be performed at six months,one year,three years, five years, ten years after surgery
Time Frame
Six months,one year, three years, five years, ten years after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhenzhen Liu, PhD
Phone
+86 13570382241
Email
liu_zhenzhen@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yizhi Liu, PhD
Organizational Affiliation
Zhongshan Ophthalmic center, Guangzhou, People's Republic of China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-sen University Guangzhou, China, 510060
City
Guangzhou
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenzhen Liu, PhD
Phone
+8613570382241
Email
liu_zhenzhen@qq.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
34653355
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 J Ophthalmol. 2022 Apr;236:183-192. doi: 10.1016/j.ajo.2021.10.006. Epub 2021 Oct 13.
Results Reference
result
PubMed Identifier
27367747
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.
Results Reference
result
PubMed Identifier
33331850
Citation
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.
Results Reference
result
PubMed Identifier
25579641
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.
Results Reference
result
PubMed Identifier
28301497
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. doi: 10.1371/journal.pone.0172979. eCollection 2017.
Results Reference
result
PubMed Identifier
25325868
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.
Results Reference
result

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

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