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

NCT01732484 | Completed Results

• 1 other identifier: EK1444/2012
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Capsule Opacification; Pseudophakia; Cataract

Outcome Measures

Primary Outcomes (1)

• 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)

  3 years

Secondary Outcomes (1)

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

  3 years

Study Arms (2)

iMics1 NY-60

OTHER

eyes with implantation of iMics1 NY-60 IOL

Procedure: intraocular lens implantation

AcrySof SN60WF

OTHER

eyes with implantation of AcrySof SN60WF IOL

Procedure: intraocular lens implantation

Interventions

intraocular lens implantation PROCEDURE

AcrySof SN60WF; iMics1 NY-60

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• bilateral age-related cataract
• good overall physical constitution

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

MeSH Terms

Conditions

Capsule Opacification; Pseudophakia; Cataract

Interventions

Lens Implantation, Intraocular

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Prof. Dr. R. Menapace
• Organization: Medical University of Vienna

rupert.menapace@meduniwien.ac.at

+43 699 19660272

Study Officials

• Rupert Menapace, MD

  Medical University Vienna

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Rupert Menapace

Study Record Dates

• First Submitted: November 19, 2012
• First Posted: November 22, 2012
• Study Start: August 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: September 1, 2012
• Last Updated: June 5, 2013
• Results First Posted: June 5, 2013

Record last verified: 2013-04