Cataract, Lens Opacities, Presbyopia
Conditions
Keywords
Intraocular lens, Trifocal
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.
Interventions
DEVICEAssigned Intervention (POD F GF)
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
Sponsors
Beaver-Visitec International, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
\[
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binocular Best corrected distance visual acuity (5 m) | 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) | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Monocular and binocular photopic uncorrected near visual acuity and binocular distance corrected visual acuity (40cm) | Postoperative Day 120-180 | DCNVA outcomes at 40cm distance |
| Binocular photopic defocus curves | Postoperative Day 120-180 | 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. |
| Binocular photopic best corrected distance visual acuity (5 m) | Postoperative Day 120-180 | DCIVA outcomes at 5m distance |
| Contrast Sensitivity under mesopic light conditions | Postoperative Day 120-180 | Contrast Sensitivity outcomes under photopic light conditions |
| Quality of Vison: VFQ-11 Questionnaire | Postoperative Day 120-180 | 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. |
| Contrast Sensitivity under photopic light conditions | Postoperative Day 120-180 | Contrast Sensitivity outcomes under photopic light conditions |
| Monocular and binocular photopic uncorrected distance visual acuity (5 m) | Postoperative Day 120-180 | UDVA outcomes at n 5m distance |
| Monocular and binocular photopic uncorrected intermediate visual acuity and binocular distance corrected intermediate visual acuity (80 cm) | Postoperative Day 120-180 | DCIVA outcomes at 80cm distance |
Countries
Japan
Outcome results
None listed