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| ID | Type | Description | Link |
|---|---|---|---|
| No. 2013021 | Other Identifier | Fudan University Eye & ENT Hospital |
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Here, we conducted a nonrandomized clinical trial aims to evaluate and compare the prognosis of visual function in children of these two types of IOL implantation over a three-year postoperative period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| toric group | Experimental | Name of Intervention: Implantation of AcrySof IQ Toric Intraocular Lens (IOL) SN6AT3-T9 Manufacturer: Alcon Laboratories, Inc. Details of Intervention: The intervention involves the surgical implantation of a toric intraocular lens (IOL) in pediatric cataract patients. This specific IOL model (SN6AT3-T9) is designed to correct astigmatism. |
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| non-toric group | Active Comparator | Name of Intervention: Implantation of AcrySof IQ Hydrophobic Acrylic Intraocular Lens (IOL) SN60WF Manufacturer: Alcon Laboratories, Inc. Details of Intervention: The control intervention involves the surgical implantation of a non-toric, hydrophobic acrylic intraocular lens (IOL) in pediatric cataract patients. This IOL model (SN60WF) provides clear vision but does not correct pre-existing corneal astigmatism. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toric IOL implantation | Device | All surgeries were performed by the same surgeon (J.Y.) using a standardized surgical technique (phacoemulsification for cataract extraction+ IOL implantation + anterior vitrectomy) under general anesthesia. Scleral tunnel incision was created firstly. Thereafter, 5.0-5.2mm anterior capsule capsulorrhexis, and cataract aspiration were performed. A single-piece hydrophobic acrylic IOL (SN6AT3-T9) was implanted into the capsular bag. After the corneal incision was closed with 10-0 sutures, a posterior capsulectomy of 3-4 mm and anterior vitrectomy were performed through the pars plana using 25-gauge instrumentation with high cutting frequency (3,000 to 4,000 cuts per minute) and low aspiration pressure (300 to 350 mm Hg) in all eyes. A 3.5-4.0 mm posterior capsule capsulorrhexis and anterior vitrectomy were performed in patients. |
| Measure | Description | Time Frame |
|---|---|---|
| BCVA at 3 years after surgery | 3 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| UDVA | Postoperative 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year, 2 years, and 3 years. | |
| CDVA | Postoperative 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year, 2 years, and 3 years | |
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Inclusion Criteria: 1) aged 3 to 8 years and diagnosed as pediatric cataract; 2) at least 2.0 D of regular corneal astigmatism.
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Exclusion Criteria: 1)history of ocular comorbidities such as such as glaucoma, retinal detachment, persistent fetal vasculature, and any retina-related pathologies; 2)history of ocular trauma or surgery; 3) concurrent severe systemic diseases; 4) lack of cooperation with slit-lamp examination, pentcam, IOL master700, subjective manifest refraction and other eye examinations.
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| Name | Affiliation | Role |
|---|---|---|
| Jin Yang, Ph.D | Fudan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye and ENT hospital Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| D000550 | Amblyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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The data analysts and investigators who observed patient outcomes during follow-up were blinded to minimize bias
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| Non-toric IOL implantation | Device | All surgeries were performed by the same surgeon (J.Y.) using a standardized surgical technique (phacoemulsification for cataract extraction+ IOL implantation + anterior vitrectomy) under general anesthesia. Scleral tunnel incision was created firstly. Thereafter, 5.0-5.2mm anterior capsule capsulorrhexis, and cataract aspiration were performed. A single-piece hydrophobic acrylic IOL (SN60WF) was implanted into the capsular bag. After the corneal incision was closed with 10-0 sutures, a posterior capsulectomy of 3-4 mm and anterior vitrectomy were performed through the pars plana using 25-gauge instrumentation with high cutting frequency (3,000 to 4,000 cuts per minute) and low aspiration pressure (300 to 350 mm Hg) in all eyes. A 3.5-4.0 mm posterior capsule capsulorrhexis and anterior vitrectomy were performed in patients. |
|
| IOP |
| Postoperative day 1, 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year, 2 years, and 3 years |
| Axial length | Postoperative 1 month, 3 months, 6 months, 1 year, 2 years, and 3 years |
| stereopsis | Postoperative 6 months, 1 year, 2 years, and 3 years |
| residual astigmatism | Postoperative 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year, 2 years, and 3 years |
| Corneal astigmatism | Postoperative 1month, 3 months, 6 months, 1 year, 2 years, and 3 years. |
| spherical equivalent | Postoperative 1 month, 3 months, 6 months, 1 year, 2 years, and 3 years. |
| IOL rotation | Postoperative 1 week, 2 weeks, and 1 month. |
| D009422 |
| Nervous System Diseases |
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |