Precisight® Intraocular Lens Implantation for Cataract Treatment

NCT02970487 | Unknown

• 1 other identifier: 2015-0023
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract Senile

Keywords

cataract

Outcome Measures

Primary Outcomes (1)

• Change of the subjective refraction

  The evolution of subjective refraction will be assessed after Precisight implantation.

  2 to 3 months, 5 to 7 months and 1 year after the investigational device implantation

Secondary Outcomes (5)

• 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

• 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

• Anterior chamber depth

  pre-operative, 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

Study Arms (1)

investigational device

EXPERIMENTAL

Subjects implanted with the Precisight intraocular lens.

Device: Intraocular implant of the Precisight

Interventions

Intraocular implant of the Precisight DEVICE

Precisight ismplanted in place of the natural cloudy lens, inside the capsular bag.

investigational device

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• InfiniteVision Optics: lead
• Targomed: collaborator

Study Sites (1)

Peregrine Eye and Laser Institue

Makati, 1209, Philippines

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Harvey S Uy, MD

  Peregrine Eye and Laser Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2016
• First Posted: November 22, 2016
• Study Start: June 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: July 1, 2020
• Last Updated: March 1, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

PH (1)