Refractive Outcome and Optimization of IOL-Constants After Implantation of the Precisight® Intraocular Lens.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 96
- Locations
- 2
- Primary Endpoint
- Change of the subjective refraction
Study Overview
Brief Summary
The purpose of this study is to determine the refractive outcomes and optimize the clinical features of a new intraocular lens intended to treat the senile cataract.
Detailed Description
InfiniteVision Optics has developed a new IOL system, the Precisight IOL. This IOL consists of a combination of two lenses: a base lens which is placed permanently into the capsular bag, and a front lens which sits on top of the base lens outside the capsular bag. The major advantage of this system is the adjustability of the primary IOL implantation which is done by front lens exchange. In case of either postoperative refractive adjustments or patient dissatisfaction with the visual performance, the front lens can be easily exchange by a less invasive surgery, avoiding a total IOL explantation. The implantation of the Precisight IOL is similar to the implantation of a traditional intraocular lens with no expected additional risk.
For all new IOLs, the IOL-constants are determined and provided by the manufacturer. They are calculated on the basis of eye models and clinical testing. In this study the biometric data of each patient's eye will be documented together with the implanted lens power and the postoperative stable refraction for calculation of the optimized IOL-constants.
In the present study, 125 subjects will be enrolled. Patients with a deviation from target refraction of more than 0.5 D spherical equivalent at the 2-3 month follow-up visit will undergo a secondary intervention for exchange of the front lens. These patients will be followed up for 1 year after front lens exchange.
Subjects will be screened during a pre-operative visit. Before the surgery visit, the subjected must have signed the Informed Consent Form.
After the surgery, patients will be followed up for one year. The visits will be scheduled at 1 day, 7-14 days, 2-3 months and 5-7 months and 1 year after surgery. Patients who underwent a surgery to exchange the front lens will be also followed up 1 day, 7-14 days, 2-3 months and 5-7 months and 1 year after the exchange surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age-related bilateral cataract or one pseudophakic eye
- •Visual acuity potential of the study eye of at least 0.63 (decimal)
- •Expected postoperative astigmatism of ≤0.75 D in the study eye
- •IOL power within available diopters
- •Written informed patient consent regarding participation in the study and data protection
Exclusion Criteria
- •Visually significant corneal scars
- •Ocular disorders - other than cataract - that could potentially cause future acuity losses to a level of 0.5 (decimal) or worse in the study eye
- •Relevant concomitant ophthalmic diseases (such as pseudoexfoliation, angleclosure glaucoma, traumatic cataract and other co-morbidity that could affect capsular bag stability (e.g. Marfan syndrome)
- •Participation of patient in other clinical trials (former participation is not an exclusion criterion)
- •Any cataract condition that makes the assessment of retina status difficult
- •Anyone with unstable systemic conditions or untreated systemic medical problems including but not limited to the following: Untreated diabetes, Cardiovascular untreated disease, Pulmonary untreated disease, Any untreated infection, Neuro-ophthalmologic diseases, Any allergy to the medications used during surgery
Arms & Interventions
investigational device
Subjects implanted with the Precisight intraocular lens.
Intervention: Intraocular implant of the Precisight (Device)
Outcomes
Primary Outcomes
Change of the subjective refraction
Time Frame: 2 to 3 months, 5 to 7 months and 1 year after the investigational device implantation
The evolution of subjective refraction will be assessed after Precisight implantation.
Secondary Outcomes
- Introcular lens (IOL) decentration and tilt(day of surgery, 2 to 3 months, 5 to 7 months and 1 year after the investigational device implantation)
- Adverse events(All follow up period (1 year))
- Assessment of investigator regarding handling and achievement of target refraction(Six months after investigational device implantation)
- Best-corrected distance visual acuity(1 day, 7 to 14 days, 2 to 3 months, 5 to 7 months and 1 year after the investigational device implantation)
- Anterior chamber depth(pre-operative, 2 to 3 months, 5 to 7 months and 1 year after the investigational device implantation)