COMPARISON OF CLINICAL OUTCOMES AND PATIENT SATISFACTION FOLLOWING BILATERAL IMPLANTATION OF TWO ADVANCED MONOFOCAL INTRAOCULAR LENSES

BIOTECH VISION CARE PVT LTD0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年5月30日

试验速览

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•1)Cataractous lens changes as demonstrated by best corrected visual acuity of 20/40 or worse with significant cataract-related visual symptoms.
•2)Best corrected visual acuity to be better than 20/30 after cataract removal and IOL implantation.
•3)<= 0.75 D of preoperative keratometric astigmatism.
•4)Clear intraocular media other than cataract.
•5)Given written informed consent by subject.
•6)Subjects are willing and able to comply with schedule for follow-up visits.
•7)Subjects should be 22 years or older.

•1)Systemic disease that could increase the operative risk or confound the outcome.
•2)Systemic medications that may confound the outcome or increase the risk to the subject in the opinion of the investigator (tamsulosin hydrochloride (Flomax) or other medications with similar side effects (floppy iris syndrome).
•3)Ocular condition that may predispose for future complications.
•4)Previous intraocular or corneal surgery that might confound the outcome of the investigation or increase the risk to the subject.
•5)Pregnant, lactating during the course of the investigation, or has another condition with associated fluctuation of hormones that could lead to refractive changes.
•6)Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause future acuity loss to 20/30 or worse.
•7)Subjects with conditions that increase the risk of zonular rupture during cataract extraction procedure that may affect the postoperative centration or tilt of the lens.
•8)If preclinical testing or risk analysis indicates potential for substantially increased light scatter over a monofocal lens, then exclude subjects who are expected to require retinal laser treatment.

发起方

BIOTECH VISION CARE PVT LTD