Secondary Intraocular Lens Implantation in Pediatric Patients
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|ClinicalTrials.gov Identifier: NCT03240796|
Recruitment Status : Recruiting
First Posted : August 7, 2017
Last Update Posted : November 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Congenital Cataract||Procedure: minimal invasive surgery and secondary IOL implantation Procedure: traditional cataract surgery and secondary IOL implantation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Secondary Intraocular Lens Implantation in Pediatric Patients: Minimal Invasive Surgery vs. Traditional Cataract Surgery for Treating Congenital Cataracts|
|Actual Study Start Date :||August 1, 2017|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||June 2019|
|Experimental: minimal invasive surgery and secondary IOL implantation||
Procedure: minimal invasive surgery and secondary IOL implantation
We decreased the size of the capsulorhexis opening to 1.0-1.5 mm in diameter and moved the location of the capsulorhexis to the peripheral area of the lens instead of the central area. A 0.9 mm phacoemulsification probe was used to remove the lens contents and/or cortical opacities. Secondary IOL implantation: implant the IOL either into the capsule bag or fix at the ciliary sulcus.
|Active Comparator: traditional cataract surgery and secondary IOL implantation||
Procedure: traditional cataract surgery and secondary IOL implantation
traditional cataract surgery: anterior continuous capsulorhexis + irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy (ACCC+ I/A + PCCC + Anti-vit).
Secondary IOL implantation: implant the IOL either into the capsule bag or fix at the ciliary sulcus.
- Best corrected visual acuity [ Time Frame: recorded at each follow-up (one week, one month, three months, six months after surgery, and every six months thereafter) ]measured using the Teller's acuity card, the Lea symbol visual acuity chart or the ETDRS chart according to the patient's age.
- Visual axis opacification [ Time Frame: recorded at each follow-up (one week, one month, three months, six months after surgery, and every six months thereafter) ]Visual axis opacification was recorded by standardized slit lamp retroillumination.
- High intraocular pressure [ Time Frame: recorded at each follow-up (one week, one month, three months, six months after surgery, and every six months thereafter) ]measured with Tono-pen tonometer
- Bi-ocular visual function [ Time Frame: The examination is performed when the patient is four years old and older, once a year. ]determined with synoptophore
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03240796
|Contact: Jing Li, M.D||+86-20-87330341||Reviewborad_SYsU@163.com|
|Zhongshan Ophthalmic Center,Sun Yat-sen U||Recruiting|
|Guangzhou, Guangdong, China, 510060|
|Contact: Haotian Lin, Phd +86-20-87330475 firstname.lastname@example.org|
|Principal Investigator: Haotian Lin, PhD|
|Principal Investigator: Yizhi Liu, PhD|
|Principal Investigator:||Haotian Lin, M.D,Ph.D||Zhongshan Ophthalmic Center, Sun Yat-sen University|