Secondary Intraocular Lens Implantation in Pediatric Patients
Study Details
Study Description
Brief Summary
This prospective, non-randomized controlled study aiming at comparing the prognosis of minimal invasive lens surgery and traditional cataract surgery for treating congenital cataracts after the patient receives secondary intraocular artificial lens (IOL) implantation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Pediatric patients received minimal invasive surgery and traditional lens removal surgery (anterior capsulorhexis and irrigation/aspiration and posterior capsulorhexis and anterior vitrectomy) are enrolled. The patients are assigned to two groups according to the strategy of primary surgery: Group I: the participants received minimal invasive surgery, while in Group II, the participants received a traditional cataract surgery. Investigators perform a secondary intraocular lens implantation for the patients. Investigators compare the visual acuity, incidence of high intraocular pressure, incidence of visual axis opacification, uveitis and iris/pupil abnormality between two groups after the first and the second surgery, aiming at comparing the prognosis of minimal invasive lens surgery and traditional cataract surgery for treating congenital cataracts.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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.
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| Active Comparator: traditional cataract surgery and secondary IOL implantation
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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.
|
Outcome Measures
Primary Outcome Measures
- Best corrected visual acuity [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.
Secondary Outcome Measures
- Visual axis opacification [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 [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 [The examination is performed when the patient is four years old and older, once a year.]
determined with synoptophore
Eligibility Criteria
Criteria
Inclusion Criteria:
Age between 24 months and 72 months Uncomplicated congenital cataract and underwent cataract removal Informed consent signed by a parent or legal guardian
Exclusion Criteria:
- Intraocular pressure >21 mmHg at enrollment Preterm birth (<28 weeks) Presence of other ocular diseases (keratitis, keratoleukoma, aniridia, glaucoma) or systemic disease (congenital heart disease, ischemic encephalopathy) History of ocular diseases (any congenital eye diseases, such as, congenital cataract, congenital glaucoma, congenital aniridia) in the family History of ocular trauma Microcornea Persistent hyperplastic primary vitreous Rubella Lowe syndrome
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhongshan Ophthalmic Center,Sun Yat-sen U | Guangzhou | Guangdong | China | 510060 |
Sponsors and Collaborators
- Sun Yat-sen University
Investigators
- Principal Investigator: Haotian Lin, M.D,Ph.D, Zhongshan Ophthalmic Center, Sun Yat-sen University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CCPMOH2017-China-4