Posterior Capsule Opacification and Frequency of Nd:YAG Treatment and of Two Microincision IOLs: Hoya iMics NY-60 vs Acrysof SN60WF
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: iMics1 NY-60 eyes with implantation of iMics1 NY-60 IOL |
Procedure: intraocular lens implantation
|
| Other: AcrySof SN60WF eyes with implantation of AcrySof SN60WF IOL |
Procedure: intraocular lens implantation
|
Outcome Measures
Primary Outcome Measures
- Posterior Capsule Opacification (PCO) [3 years]
PCO = migration of lens epithelial cells behind the IOL optic after cataract surgery; scale 0-10 (0: no PCO; 10: maximum PCO)
Secondary Outcome Measures
- Percentage of Eyes With Neodymium:Yttrium-aluminium-garnet (Nd:YAG) Capsulotomy [3 years]
Treatment of PCO in neodymium:yttrium-aluminium-garnet (Nd:YAG) capsulotomy. The frequency of this treatment will be asseseed in percentage values
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Medical University of Vienna
Investigators
- Principal Investigator: Rupert Menapace, MD, Medical University Vienna
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EK1444/2012
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Patients Included |
|---|---|
| Arm/Group Description | |
| Period Title: Overall Study | |
| STARTED | 100 |
| Randomized | 100 |
| Allocation | 100 |
| COMPLETED | 74 |
| NOT COMPLETED | 26 |
Baseline Characteristics
| Arm/Group Title | Cataract Surgery |
|---|---|
| Arm/Group Description | eyes with implantation of iMics1 NY-60 IOL or Acrysof SN60WF IOL |
| Overall Participants | 100 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
0
0%
|
| >=65 years |
100
100%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
72
(9)
|
| Gender (participants) [Number] | |
| Female |
42
42%
|
| Male |
32
32%
|
| Region of Enrollment (participants) [Number] | |
| Austria |
100
100%
|
Outcome Measures
| Title | Posterior Capsule Opacification (PCO) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | iMics1 NY-60 | AcrySof SN60WF |
|---|---|---|
| Arm/Group Description | eyes with implantation of iMics1 NY-60 IOL | eyes with implantation of AcrySof SN60WF IOL |
| Measure Participants | 74 | 74 |
| Mean (Standard Deviation) [units on a scale (0-10)] |
3.0
(2.0)
|
1.9
(1.4)
|
| Title | Percentage of Eyes With Neodymium:Yttrium-aluminium-garnet (Nd:YAG) Capsulotomy |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | iMics1 NY-60 | AcrySof SN60WF |
|---|---|---|
| Arm/Group Description | eyes with implantation of iMics1 NY-60 IOL | eyes with implantation of AcrySof SN60WF IOL |
| Measure Participants | 74 | 74 |
| Measure eyes | 148 | 148 |
| Number [percentage of eyes] |
26
(0)
|
10
(0)
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | iMics1 NY-60 | AcrySof SN60WF | ||
| Arm/Group Description | eyes with implantation of iMics1 NY-60 IOL | eyes with implantation of AcrySof SN60WF IOL | ||
All Cause Mortality |
||||
| iMics1 NY-60 | AcrySof SN60WF | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| iMics1 NY-60 | AcrySof SN60WF | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/100 (0%) | 0/100 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| iMics1 NY-60 | AcrySof SN60WF | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/100 (0%) | 0/100 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Prof. Dr. R. Menapace |
|---|---|
| Organization | Medical University of Vienna |
| Phone | +43 699 19660272 |
| rupert.menapace@meduniwien.ac.at |
- EK1444/2012