Clinical Investigation of the Multifocal IOL POD F GF in Cataracteous Eyes

This is an interventional treatment trial for Cataract focused on measuring Intraocular lens, Trifocal Read More

Inclusion Criteria:

1. Adults, 20 years of age or older at the time of informed consent, of either gender, diagnosed with bilateral cataracts;
2. Able to comprehend and sign a statement of informed consent;
3. Willing and able to complete all required postoperative visits;
4. Calculated lens power within the available range;
5. Planned cataract removal by phacoemulsification;
6. Potential postoperative BCDVA of 0.5 decimal or better in both eyes;
7. Subject with preoperative astigmatism < 1.0 D
8. Clear intraocular media other than cataract in both eyes;
9. The subject must be able to undergo second eye surgery within 30 days of the first eye surgery.

[Justification for the inclusion criteria]

1. and 5: Cataract extraction is the indication of the clinical study.
2. and 3: One of GCP requirements 4: Essential condition for implant of the investigational lens. 6, 7, 8 and 9: Conditions to minimize the potential non-IOL factors which may affect the visual acuity data

Exclusion Criteria:

[Exclusion Criteria Prior to Surgery] The patient who meets any criteria specified in the following 1) through 22).

1. Irregular corneal aberration that affects postoperative visual function as demonstrated by corneal topography;
2. Inflammation or edema (swelling) of the cornea affecting post-operative visual acuity;
3. 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;
4. Subjects who may be expected to require ocular surgery (other than blepharo-surgery, laser surgery of fundus and YAG capsulotomy) during the study;
5. Previous refractive surgery;
6. Amblyopia;
7. Clinically severe corneal dystrophy (eg., epithelial, stromal, or endothelial dystrophy), keratitis, keratoconjunctivitis, keratouveitis, keratopathy, or kerectasia;
8. Diabetic retinopathy;
9. Extremely shallow anterior chamber, not due to swollen cataract;
10. Microphthalmos;
11. Current or previous retinal detachment;
12. Previous corneal transplant;
13. Recurrent severe anterior or posterior segment inflammation of unknown etiology;
14. Rubella or traumatic cataract;
15. Iris neovascularization;
16. Glaucoma or ocular hypertension;
17. Aniridia;
18. Optic nerve atrophy;
19. Planned clear lensectomy (no lens opacity)
20. Pregnancy, lactating or possible pregnant;
21. Participation in any clinical study (drug or device) within 3 months prior to participating this study, planned participation another clinical study during this study, or currently participating in another study.
22. Disqualified by the investigator or the sub-investigator because of physical or ophthalmic diseases.

[Exclusion Criteria During Surgery] The patient who meets any criteria specified in the following 1) through 7).

1. Mechanical or surgical manipulation required to enlarge the pupil;
2. Excessive iris mobility;
3. Significant vitreous loss;
4. Significant anterior chamber hyphema;
5. Uncontrollable intraocular pressure;
6. Zonular or capsular rupture or tear;
7. IOL could not be fixed in the lens capsule;