Precisight® Intraocular Lens Implantation for Cataract Treatment

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02970487
• Date of registration: 10/11/2016
• Prospective Registration: No
• Primary sponsor: InfiniteVision Optics
• Public title: Precisight® Intraocular Lens Implantation for Cataract Treatment PEACE
• Scientific title: Refractive Outcome and Optimization of IOL-Constants After Implantation of the Precisight® Intraocular Lens.
• Date of first enrolment: June 2016
• Target sample size: 96
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02970487
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Philippines

Contacts

• Name: Harvey S Uy, MD
• Affiliation: Peregrine Eye and Laser Institute

Key inclusion & exclusion criteria

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



Age minimum: 50 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cataract Senile

Intervention(s)

Device: Intraocular implant of the Precisight

Primary Outcome(s)

Change of the subjective refraction [Time Frame: 2 to 3 months, 5 to 7 months and 1 year after the investigational device implantation]

Secondary Outcome(s)

Adverse events [Time Frame: All follow up period (1 year)]

Best-corrected distance visual acuity [Time Frame: 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 [Time Frame: pre-operative, 2 to 3 months, 5 to 7 months and 1 year after the investigational device implantation]

Assessment of investigator regarding handling and achievement of target refraction [Time Frame: Six months after investigational device implantation]

Introcular lens (IOL) decentration and tilt [Time Frame: day of surgery, 2 to 3 months, 5 to 7 months and 1 year after the investigational device implantation]

Secondary ID(s)

2015-0023

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Targomed