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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Secondary in-the-bag IOL fixation group | Experimental | In-the-bag IOL fixation is the experimental arm |
|
| Secondary ciliary sulcus IOL fixation group | Active Comparator | Ciliary sulcus IOL fixation is the control arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secondary in-the-bag IOL fixation | Procedure | The experimental group with secondary IOL fixated in the capsular bag |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of glaucoma-related adverse events | The assessment of glaucoma-related adverse events is performed at one year after surgery | One year after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Visual acuity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhenzhen Liu, PhD | Contact | +86 13570382241 | liu_zhenzhen@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Yizhi Liu, PhD | Zhongshan Ophthalmic center, Guangzhou, People's Republic of China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Ophthalmic Center, Sun Yat-sen University Guangzhou, China, 510060 | Recruiting | Guangzhou | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34653355 | Result | 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. | |
| 27367747 |
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| Secondary ciliary sulcus IOL fixation | Procedure | The control group with secondary IOL fixated in the ciliary sulcus |
|
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 |
| Ocular refractive power | Measured by the Auto Refractometer | Six months,one year,three years, five years, ten years after surgery |
| Intraocular lens decentration | Measured by anterior segment scanning | Six months,one year, three years, five years, ten years after surgery |
| Intraocular lens tilt | Measured by anterior segment scanning | Six months,one year, three years, five years, ten years after surgery |
| 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 |
| 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. |
| 33331850 | 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. |
| 25579641 | 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. |
| 28301497 | 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. |
| 25325868 | 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. |
| 37296411 | Derived | 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. |