Clinical Investigation of the Multifocal Intraocular Lens (IOL) POD F GF in Cataracteous Eyes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cataract
- Sponsor
- Beaver-Visitec International, Inc.
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Binocular Best corrected distance visual acuity (5 m)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
To evaluate effectiveness and safety of the POD F GF Intraocular Lens (IOL) when implanted to replace the natural lens following cataract removal
Detailed Description
Since the investigational lens, like conventional IOLs, is a posterior chamber lens which is widely implanted following cataract extraction, phacoemulsification is adopted. To assess the binocular vision, the investigational lens will be bilaterally implanted. Considering the safety of the study subjects, the time of implant to the remaining eye (2nd eye) will be decided based on the results of the 1st implant.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults, 20 years of age or older at the time of informed consent, of either gender, diagnosed with bilateral cataracts;
- •Able to comprehend and sign a statement of informed consent;
- •Willing and able to complete all required postoperative visits;
- •Calculated lens power within the available range;
- •Planned cataract removal by phacoemulsification;
- •Potential postoperative BCDVA of 0.5 decimal or better in both eyes;
- •Subject with preoperative astigmatism \< 1.0 D
- •Clear intraocular media other than cataract in both eyes;
- •The subject must be able to undergo second eye surgery within 30 days of the first eye surgery.
- •\[Justification for the inclusion criteria\]
Exclusion Criteria
- •\[Exclusion Criteria Prior to Surgery\] The patient who meets any criteria specified in the following 1) through 22).
- •Irregular corneal aberration that affects postoperative visual function as demonstrated by corneal topography;
- •Inflammation or edema (swelling) of the cornea affecting post-operative visual acuity;
- •Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level worse than 0.5 decimal for BCDVA;
- •Subjects who may be expected to require ocular surgery (other than blepharo-surgery, laser surgery of fundus and YAG capsulotomy) during the study;
- •Previous refractive surgery;
- •Clinically severe corneal dystrophy (eg., epithelial, stromal, or endothelial dystrophy), keratitis, keratoconjunctivitis, keratouveitis, keratopathy, or kerectasia;
- •Diabetic retinopathy;
- •Extremely shallow anterior chamber, not due to swollen cataract;
- •Microphthalmos;
Outcomes
Primary Outcomes
Binocular Best corrected distance visual acuity (5 m)
Time Frame: Postoperative Day 120-180 (4-6 months)
CDVA measured with ETDRS charts placed in 5m distance with best aided corrective glasses according to ISO 11979-7:2014.
Binocular Distance corrected near visual acuity (40 cm)
Time Frame: Postoperative Day 120-180 (4-6 months)
DCIVA measured with ETDRS charts placed in 40cm distance with corrective glasses for far distance according to ISO 11979-7:2014.
Binocular Distance corrected intermediate visual acuity (80 cm)
Time Frame: Postoperative Day 120-180 (4-6 months)
DCIVA measured with ETDRS charts placed in 80cm distance with corrective glasses for far distance according to ISO 11979-7:2014.
Secondary Outcomes
- Binocular photopic defocus curves(Postoperative Day 120-180)
- Quality of Vison: VFQ-11 Questionnaire(Postoperative Day 120-180)
- Monocular and binocular photopic uncorrected distance visual acuity (5 m)(Postoperative Day 120-180)
- Monocular and binocular photopic uncorrected near visual acuity and binocular distance corrected visual acuity (40cm)(Postoperative Day 120-180)
- Contrast Sensitivity under mesopic light conditions(Postoperative Day 120-180)
- Binocular photopic best corrected distance visual acuity (5 m)(Postoperative Day 120-180)
- Monocular and binocular photopic uncorrected intermediate visual acuity and binocular distance corrected intermediate visual acuity (80 cm)(Postoperative Day 120-180)
- Contrast Sensitivity under photopic light conditions(Postoperative Day 120-180)