Secondary Intraocular Lens Implantation in Pediatric Patients: Minimal Invasive Surgery vs. Traditional Cataract Surgery for Treating Congenital Cataracts
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Best corrected visual acuity
Study Overview
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.
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
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 24 Months to 72 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
minimal invasive surgery and secondary IOL implantation
Intervention: minimal invasive surgery and secondary IOL implantation (Procedure)
traditional cataract surgery and secondary IOL implantation
Intervention: traditional cataract surgery and secondary IOL implantation (Procedure)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Visual axis opacification(recorded at each follow-up (one week, one month, three months, six months after surgery, and every six months thereafter))
- High intraocular pressure(recorded at each follow-up (one week, one month, three months, six months after surgery, and every six months thereafter))
- Bi-ocular visual function(The examination is performed when the patient is four years old and older, once a year.)
Investigators
Haotian Lin
Clinical Professor
Sun Yat-sen University