Status:
COMPLETED
Clinical Investigation of the Multifocal IOL POD F GF in Cataracteous Eyes
Lead Sponsor:
Beaver-Visitec International, Inc.
Conditions:
Cataract
Lens Opacities
Eligibility:
All Genders
20+ years
Phase:
NA
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 vis...
Eligibility Criteria
Inclusion
- 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.
- \[Justification for the inclusion criteria\]
- and 5: Cataract extraction is the indication of the clinical study.
- 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
- \[Exclusion Criteria Prior to Surgery\] 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;
- Amblyopia;
- 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;
- Current or previous retinal detachment;
- Previous corneal transplant;
- Recurrent severe anterior or posterior segment inflammation of unknown etiology;
- Rubella or traumatic cataract;
- Iris neovascularization;
- Glaucoma or ocular hypertension;
- Aniridia;
- Optic nerve atrophy;
- Planned clear lensectomy (no lens opacity)
- Pregnancy, lactating or possible pregnant;
- 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.
- 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).
- Mechanical or surgical manipulation required to enlarge the pupil;
- Excessive iris mobility;
- Significant vitreous loss;
- Significant anterior chamber hyphema;
- Uncontrollable intraocular pressure;
- Zonular or capsular rupture or tear;
- IOL could not be fixed in the lens capsule;
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2021
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04699266
Start Date
November 1 2020
End Date
August 30 2021
Last Update
August 1 2023
Active Locations (1)
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1
Miyata Eye Hospital
Miyata, Japan