Artisan Aphakia Lens for the Correction of Aphakia in Children
Investigating an Intraocular Lens for Aphakia (a condition where the eye's lens is missing) in Children
David Plager, MD
Primary Investigator
Brief description of study
Detailed description of study
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Aphakia, Visually significant cataract, Riley
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Age: 2 years - 21 years
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Gender: All
Criteria for Inclusion:
Implantation of the ARTISAN® Aphakia Lens may be indicated in the following conditions:
1. Patients age 2 to 21 years of age at the time of the baseline visit, of either sex, and of any race that have a visually significant cataract (in preoperative phakic eyes) or need IOL replacement surgery (in preoperative aphakic or pseudophakic eyes) and have a subluxated capsule, weakened zonules or otherwise compromised capsular bag prohibiting implantation of a standard posterior chamber IOL such as in Marfan’s syndrome, ectopia lentis or other pathology.
2. Subject’s legally authorized representative (parent or guardian) must be able to understand and sign the informed consent form that has been approved by the Institutional Review Board.
3. Parent or guardian must agree to comply with the visit schedule and other requirements of the study.
The physician should determine whether any of the following circumstances may create an undue risk when considering implanting an ARTISAN® Aphakia Lens. Investigators considering implantation in such patients should explore the use of alternative methods of correction and consider lens implantation only if alternatives are deemed unsatisfactory to meet the needs of the patient:
Exclusion criteria:
1. Patients under 2 years of age
2. Patients that are not able to meet the extensive postoperative evaluation requirements
3. When the patient has no useful vision or vision potential in the fellow eye
4. Mentally retarded patients
5. History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.), corneal dystrophy, degeneration, opacities or abnormalities that may affect vision.
6. Abnormality of the iris or ocular structure which would preclude fixation, such as aniridia, hemiiridectomy, severe iris atrophy, rubeosis iridis, or other compromising iris pathology
7. Patients with an anterior chamber depth less than 3.2mm
8. Patients with uncontrolled glaucoma
9. High preoperative intraocular pressure(>25 mmHg)
10. Chronic or recurrent uveitis or history of the same
11. Preexisting macular pathology that may complicate the ability to assess the benefit or lack of benefit obtained by the lens
12. Patients with a retinal detachment or a family history of retinal detachment
13. Retinal disease that may limit the visual potential of the eye such as retinopathy of prematurity or Stargardt’s retinopathy
14. Optic nerve disease that may limit the visual potential of the eye
15. Diabetes mellitus
16. Pregnant, lactating, or plans to become pregnant during the course of the study
This study investigates the use of an intraocular lens for children with aphakia, a condition where the eye's lens is missing. The purpose of this study is to evaluate how safe and effective the lens is for children who need this type of eye surgery. Aphakia can occur due to various conditions, such as cataracts or other eye problems, which can affect vision.
The study procedures include checking how well the child can see, measuring eye pressure, and examining the health of the eye, including the cornea and retina. These are standard tests done during eye surgeries for children. The study will also involve taking pictures of the cells inside the eye and checking for any issues after surgery.
- Who can participate: Children aged 2 to 21 years with visually significant cataracts or requiring lens replacement surgery can participate. They must have specific eye conditions preventing standard lens implantation and parental consent is required.
- Study details: Participants will undergo standard eye tests and evaluations during their usual office visits, including vision and eye pressure measurements, and eye health checks. The study involves routine procedures for children undergoing eye surgery.
- Study timelines and visits: The study will last five years. The study requires 8 visits.
