Trial Outcomes & Findings for Posterior Capsule Opacification and Frequency of Nd:YAG Treatment and of Two Microincision IOLs: Hoya iMics NY-60 vs Acrysof SN60WF (NCT NCT01732484)

Results Overview

PCO = migration of lens epithelial cells behind the IOL optic after cataract surgery; scale 0-10 (0: no PCO; 10: maximum PCO)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

100 participants

Primary outcome timeframe

3 years

Results posted on

2013-06-05

Participant Flow

Participant milestones

Participant milestones
Measure	Patients Included
Overall Study STARTED	100
Overall Study Randomized	100
Overall Study Allocation	100
Overall Study COMPLETED	74
Overall Study NOT COMPLETED	26

Reasons for withdrawal

Reasons for withdrawal
Measure	Patients Included
Overall Study Death	7
Overall Study Lost to Follow-up	14
Overall Study chronical illness	5

Baseline Characteristics

Posterior Capsule Opacification and Frequency of Nd:YAG Treatment and of Two Microincision IOLs: Hoya iMics NY-60 vs Acrysof SN60WF

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cataract Surgery n=100 Participants eyes with implantation of iMics1 NY-60 IOL or Acrysof SN60WF IOL
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	100 Participants n=5 Participants
Age Continuous	72 years STANDARD_DEVIATION 9 • n=5 Participants
Gender Female	42 participants n=5 Participants
Gender Male	32 participants n=5 Participants
Region of Enrollment Austria	100 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years

PCO = migration of lens epithelial cells behind the IOL optic after cataract surgery; scale 0-10 (0: no PCO; 10: maximum PCO)

Outcome measures

Outcome measures
Measure	iMics1 NY-60 n=74 Participants eyes with implantation of iMics1 NY-60 IOL	AcrySof SN60WF n=74 Participants eyes with implantation of AcrySof SN60WF IOL
Posterior Capsule Opacification (PCO)	3.0 units on a scale (0-10) Standard Deviation 2.0	1.9 units on a scale (0-10) Standard Deviation 1.4

SECONDARY outcome

Timeframe: 3 years

Treatment of PCO in neodymium:yttrium-aluminium-garnet (Nd:YAG) capsulotomy. The frequency of this treatment will be asseseed in percentage values

Outcome measures

Outcome measures
Measure	iMics1 NY-60 n=148 eyes eyes with implantation of iMics1 NY-60 IOL	AcrySof SN60WF n=148 eyes eyes with implantation of AcrySof SN60WF IOL
Percentage of Eyes With Neodymium:Yttrium-aluminium-garnet (Nd:YAG) Capsulotomy	26 percentage of eyes 0	10 percentage of eyes 0

Adverse Events

iMics1 NY-60

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

AcrySof SN60WF

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Dr. R. Menapace

Medical University of Vienna

Phone: +43 699 19660272

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place