Clinical Investigation of POD F GF

JRCT ID: jRCT2072200052

Registered date:13/11/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Cataract
• Date of first enrollment: 26/10/2020
• Target sample size: 22
• Study type: Interventional
• Intervention(s): Cataract Surgery

Outcome(s)

Primary Outcome

-Best corrected distance visual acuity (5 m) at Visit 4A (Postoperative Day 120-180)
-Distance corrected near visual acuity (40 cm) at Visit 4A (Postoperative Day 120-180)
-Distance corrected intermediate visual acuity (80 cm) at Visit 4A (Postoperative Day 120-180)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Maeda Naoyuki