Clinical Investigation of POD F GF

Phase 3

• Conditions: Cataract

• Registration Number: JPRN-jRCT2072200052
• Lead Sponsor: Maeda Naoyuki

Brief Summary

Visual acuity at 120-180 days postoperatively was demonstrated to be noninferior to that of the approved monofocal IOL for distance-corrected visual acuity (5 m) and superior for distance-corrected intermediate visual acuity (80 cm) and distance-corrected near visual acuity (40 cm). No AEs related to the study device were reported. Based on the efficacy and safety results shown in this clinical trial, this investigational lens is considered clinically useful.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-13
• Study Completion: 2021-08-30
• Results First Posted: 2022-12-21
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Subject with preoperative astigmatism < 1.0 D
- The subject must be able to undergo second eye surgery within 30 days of the first eye surgery.
- Other protocol-specified inclusion criteria may apply.

Exclusion Criteria

- Irregular corneal aberration that affects postoperative visual function as demonstrated by corneal topography;
- 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 CDVA;
- 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;
- Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: Interventional
• Study Design: Not specified