Skip to content

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01732484
Enrollment
100
Registered
2012-11-22
Start date
2009-08-31
Completion date
2012-09-30
Last updated
2013-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Capsule Opacification, Pseudophakia, Cataract

Brief summary

Age-related cataract is the main cause of impaired vision in the elderly population worldwide. In the UK, more than half of people who are over 65 have some cataract development in one or both eyes. The only treatment that can restore functional visual ability is cataract surgery where the opacified crystalline lens is removed by phacoemulsification and an artificial intraocular lens is implanted. It is estimated that around 10 million cataract operations are performed around the world each year. Cataract operations are generally very successful, with a low risk of serious complications. The most common risk is developing a condition called posterior capsule opacification (PCO), which causes impaired vision to return. During the past two decades, cataract surgery underwent tremendous change and modernisation resulting in today's small incision phacoemulsification surgery and a safe technique with a short rehabilitation time for the patient. The most frequent long-term complication of cataract surgery remains to be posterior capsule opacification (PCO). In the past few years, refinements in surgical technique and modifications in IOL design and material have led to a decrease in the incidence of PCO. It has been shown that a sharp posterior optic edge inhibits migration of lens epithelial cells (LEC) behind the IOL optic and therefore have a lower incidence of posterior capsule opacification (PCO). Most IOL designs have open-loop haptics that are connected to the optic towards the end of the production process, also called multipiece designs. For several reasons such as better ease of use with injector systems and higher efficiency in the production process, companies have developed IOLs with open-loop haptics out of one block of material, also called single-piece designs. In the case of such single-piece IOLs, the haptics tend to be much thicker than with multipiece IOLs. A potential drawback of the thick haptics maybe an incomplete closure of the capsule at the optic rim with a reduced bending effect of the posterior capsule around the posterior optic edge. Additionally, the posterior sharp edge is often discontinuous in the region of the haptic-optic junctions. These locations may serve as a scaffold for LECs to migrate behind the IOL optic resulting in PCO. Nowadays a multitude of different single piece IOLS are available, many of them similar but of course with some differences in regard to the chemical composition of the acrylic material and the IOL design. The purpose of this study is to compare the intensity of posterior capsule opacification (PCO) between two different 1-piece foldable hydrophobic acrylic intraocular lenses (IOLs) over a period of 3 years.

Interventions

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* bilateral age-related cataract * good overall physical constitution

Exclusion criteria

* history of ocular disease or intraocular surgery * laser treatment * diabetes requiring medical control * glaucoma * severe retinal pathology that would make a postoperative visual acuity of 20/40 (decimal equivalent = 0.5) or better unlikely

Design outcomes

Primary

MeasureTime frameDescription
Posterior Capsule Opacification (PCO)3 yearsPCO = migration of lens epithelial cells behind the IOL optic after cataract surgery; scale 0-10 (0: no PCO; 10: maximum PCO)

Secondary

MeasureTime frameDescription
Percentage of Eyes With Neodymium:Yttrium-aluminium-garnet (Nd:YAG) Capsulotomy3 yearsTreatment of PCO in neodymium:yttrium-aluminium-garnet (Nd:YAG) capsulotomy. The frequency of this treatment will be asseseed in percentage values

Participant flow

Participants by arm

ArmCount
Cataract Surgery
eyes with implantation of iMics1 NY-60 IOL or Acrysof SN60WF IOL
100
Total100

Withdrawals & dropouts

PeriodReasonFG000
Overall Studychronical illness5
Overall StudyDeath7
Overall StudyLost to Follow-up14

Baseline characteristics

CharacteristicCataract Surgery
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
100 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Age Continuous72 years
STANDARD_DEVIATION 9
Gender
Female
42 participants
Gender
Male
32 participants
Region of Enrollment
Austria
100 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 1000 / 100
serious
Total, serious adverse events
0 / 1000 / 100

Outcome results

Primary

Posterior Capsule Opacification (PCO)

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

Time frame: 3 years

ArmMeasureValue (MEAN)Dispersion
iMics1 NY-60Posterior Capsule Opacification (PCO)3.0 units on a scale (0-10)Standard Deviation 2
AcrySof SN60WFPosterior Capsule Opacification (PCO)1.9 units on a scale (0-10)Standard Deviation 1.4
Secondary

Percentage of Eyes With Neodymium:Yttrium-aluminium-garnet (Nd:YAG) Capsulotomy

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

Time frame: 3 years

ArmMeasureValue (NUMBER)Dispersion
iMics1 NY-60Percentage of Eyes With Neodymium:Yttrium-aluminium-garnet (Nd:YAG) Capsulotomy26 percentage of eyes 0
AcrySof SN60WFPercentage of Eyes With Neodymium:Yttrium-aluminium-garnet (Nd:YAG) Capsulotomy10 percentage of eyes 0

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026