NIPH Clinical Trials Search

Clinical Investigation of POD F GF

Basic Information

Recruitment status	Complete
Health condition(s) or Problem(s) studied	Cataract
Date of first enrollment	26/10/2020
Target sample size	22
Countries of recruitment
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)
Secondary Outcome

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.