Congenital Cataract Clinical Trial
Official title:
Aphakia vs Pseudophakia - Randomized Clinical Trial in Children Under 2 Years Undergoing Bilateral Congenital Cataract Surgery
The purpose of this study is to document the safety and efficacy of primary IOL implantation in children below 2 years of age undergoing congenital cataract surgery.
The use of IOLs in pediatric patients has become increasingly popular in recent years and
may represent a standard of care for older children. The refinements in surgical techniques
attained in adult cataract surgery have been translated to pediatric cataract surgery to
produce a technically safe eye. Nevertheless, the use of IOLs in children younger than 2
years remains controversial. Exaggerated inflammation, capsular opacification and changing
refractive status of the developing eye should be considered before the use of IOLs in the
first two years of life. Further more, there is concern about the unknown risks of an IOL
over the long life span.
Currently, there are 3 methods of optical rehabilitation following congenital cataract
surgery :
1. Primary IOL implantation.
2. Aphakic glasses.
3. Contact lenses.
At present, there is no randomized clinical trial reported to document the safety and
efficacy of IOL implantation in children less than 2 years.
Aim : To compare the technical outcome (safety) and functional outcome (benefits) following
primary IOL implantation and aphakia in children less than 2 years.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05275764 -
Comparison of the Efficacy of Intraocular Lens Optic Capture and In-the-bag Implantation Over 1 Year in Children With Congenital Cataract
|
||
Recruiting |
NCT05136209 -
Comparison of Posterior Continuous Curvilinear Capsulorhexis With or Without Anterior Vitrectomy
|
N/A | |
Recruiting |
NCT03342794 -
Morphologic and Biometric Characteristics of Preexisting Posterior Capsule Defects in Congenital Cataracts During the First Year of Life
|
N/A | |
Completed |
NCT04120818 -
Inflammatory Cytokines in Congenital Cataract After Lensectomy and Anterior Vitrectomy
|
||
Recruiting |
NCT04824963 -
Analysis of Related Factors Affecting the Secondary Implantation of Intraocular Lens in Congenital Cataract
|
||
Recruiting |
NCT04323982 -
Comparison of Traditional Cataract Surgery and Traditional Surgery Combined Triamcinolone Staining
|
N/A | |
Completed |
NCT02158325 -
Capsulorhexis Size and Capsular Outcome
|
N/A | |
Completed |
NCT03621579 -
Analysis of Retinal Nerve Fiber Layer and Macular Thickness After Congenital Cataract Surgery
|
N/A | |
Recruiting |
NCT03564990 -
The Impact of Interactive, Multifaceted Approach Education on Congenital Cataract
|
N/A | |
Not yet recruiting |
NCT05282147 -
Digital Imaging Versus Ophthalmoscopy
|
N/A | |
Not yet recruiting |
NCT03125785 -
The Effect of Ophthalmic Solutions on Contact Lenses Used After Surgery for Congenital Cataract Investigated in Vivo
|
N/A | |
Recruiting |
NCT04976608 -
Relationship of Retinal and Visual Cortex Structure and Visual Acuity After Congenital Cataract Surgery
|
||
Completed |
NCT03778086 -
Iridocorneal Angle and Anterior Segment Structure in Eyes of Children With Cataract
|
||
Recruiting |
NCT03230799 -
Comparison of Minimal Invasive Lens Surgery and Traditional Cataract Surgery
|
N/A | |
Recruiting |
NCT04759560 -
Biometric Characteristics of the Eye With Microcornea/Microphthalmia and Congenital Cataract Before And After Cataract Extraction
|
||
Completed |
NCT02132312 -
A Randomized Study in Children Ages Birth Through Three Years Undergoing Unilateral Cataract Extraction With or Without Lens Replacement
|
Phase 3 | |
Completed |
NCT01136473 -
Mechanism of Aphakic and Pseudophakic Glaucoma in Pediatric Patients
|
N/A | |
Completed |
NCT03242629 -
Comparison Between Oral and Enema of Chloral Hydrate
|
N/A | |
Completed |
NCT04077489 -
Effects of 23-gauge Lensecotomy Combined With Anterior Vitrectomy on Macular in Children With Congenital Cataract
|
N/A | |
Active, not recruiting |
NCT05451745 -
Glaucoma Following Pediatric Cataract Surgery
|