To evaluate effectiveness and safety of the POD F GF Intraocular Lens (IOL) when implanted to replace the natural lens following cataract removal
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
The investigational lens (POD F GF )will be implanted to both eyes in subjects with bilateral cataract. Registration of patients and the implantation of the investigational lens (POD F GF) will be conducted in consideration of securing 44 eyes in 22 subjects as the analysis subjects
Miyata Eye Hospital
Miyata, Japan
Binocular Best corrected distance visual acuity (5 m)
CDVA measured with ETDRS charts placed in 5m distance with best aided corrective glasses according to ISO 11979-7:2014.
Time frame: Postoperative Day 120-180 (4-6 months)
Binocular Distance corrected near visual acuity (40 cm)
DCIVA measured with ETDRS charts placed in 40cm distance with corrective glasses for far distance according to ISO 11979-7:2014.
Time frame: Postoperative Day 120-180 (4-6 months)
Binocular Distance corrected intermediate visual acuity (80 cm)
DCIVA measured with ETDRS charts placed in 80cm distance with corrective glasses for far distance according to ISO 11979-7:2014.
Time frame: Postoperative Day 120-180 (4-6 months)
Binocular photopic best corrected distance visual acuity (5 m)
DCIVA outcomes at 5m distance
Time frame: Postoperative Day 120-180
Monocular and binocular photopic uncorrected distance visual acuity (5 m)
UDVA outcomes at n 5m distance
Time frame: Postoperative Day 120-180
Monocular and binocular photopic uncorrected intermediate visual acuity and binocular distance corrected intermediate visual acuity (80 cm)
DCIVA outcomes at 80cm distance
Time frame: Postoperative Day 120-180
Monocular and binocular photopic uncorrected near visual acuity and binocular distance corrected visual acuity (40cm)
DCNVA outcomes at 40cm distance
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Time frame: Postoperative Day 120-180
Binocular photopic defocus curves
To assess the visual acuity for different distances, defocus curves under photopic light conditions are measured. This test is performed with best distance corrected refraction and spherical additions ranging from -5.0 D to +1.5 D.
Time frame: Postoperative Day 120-180
Contrast Sensitivity under photopic light conditions
Contrast Sensitivity outcomes under photopic light conditions
Time frame: Postoperative Day 120-180
Contrast Sensitivity under mesopic light conditions
Contrast Sensitivity outcomes under photopic light conditions
Time frame: Postoperative Day 120-180
Quality of Vison: VFQ-11 Questionnaire
Outcomes measures of a questionnaire to address the general patient satisfaction and possible side effects of the treatment. For this study, the validated and verified Visual Functioning Questionnaire - 25 (VFQ-25) will be used. The maximum score for each questionaire is 100.
Time frame: Postoperative Day 120-180