Long-term Evaluation of Single-piece ACrysof IOL Implantation on Development of Posterior Capsule Opacification

NCT ID: NCT01820065

Last Updated: 2013-03-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 390 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2011-10-31

Brief Summary

Although contemporary cataract surgery has made tremendous strides in technological advancement, posterior capsular opacification (PCO) is still the most frequent long-term complication leading to decreased visual functions and thereby dissatisfying results. A great deal of effort has been made to develop new ways to prevent the formation of PCO. A key factor, widely discussed in literature, is the material and design of the intraocular lense (IOL) edge that can lead to PCO prevention. It is still not clear whether the sharp-edged IOL produces less PCO because of its optic geometry alone or whether the biomaterial contributes to the inhibition of PCO. With the clinical introduction of the single-piece acrylic hydrophobic IOLs with some optic and haptic design differences compared with three-piece acrylic hydrophobic IOLs, it has become possible to determine the influence of IOL material and design on PCO prevention. It is well established that the development of PCO is a dynamic process and that a longer follow-up time is correlated with a higher degree of PCO. So far, there have been prospective clinical studies on the clinical results of single and three-piece acrylic hydrophobic foldable IOLs. However, the question as to as to whether the PCO further increases or becomes stable or regresses on a long-term basis has not yet been answered. Since there is paucity of available literature that prospectively evaluates the development of PCO with the implantation of the single-piece SN60AT hydrophobic acrylic IOL on a long-term basis, the investigators decided to observe the degree of development of PCO at 5 years after cataract surgery.

Conditions

Posterior Capsule Opacification After Phacoemulsification and IOL Implantation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients undergoing phacoemulsification

Patients undergoing phacoemulsification for age-related cataract with implantation of a single-piece Acrysof IOL (SN60AT)

Cataract surgery with IOL implantation

Intervention Type: PROCEDURE

Phacoemulsification with implantation of single piece Acrysof IOL

Interventions

Cataract surgery with IOL implantation

Phacoemulsification with implantation of single piece Acrysof IOL

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• patients with uncomplicated age-related cataract who were otherwise healthy

Exclusion Criteria

• a history of diabetes mellitus (DM),
• patients with glaucoma,
• high myopia (axial length > 27.0 mm),
• pseudoexfoliation,
• traumatic cataract,
• subluxated cataract,
• previous ocular surgeries, and
• allergy to dilating drops.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Iladevi Cataract and IOL Research Center

OTHER

Sponsor Role: lead

Responsible Party

Abhay R. Vasavada

Director, Iladevi Cataract and IOL Research Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abhay R Vasavada, MS, FRCS

Role: PRINCIPAL_INVESTIGATOR

Iladevi Cataract & IOL Research Centre

Abhay R Vasavada, MS,FRCS

Role: PRINCIPAL_INVESTIGATOR

Iladevi Cataract & IOL Research Centre

Locations

Iladevi Cataract & IOL Research Centre

Ahmedabad, Gujarat, India

Countries

India

Other Identifiers

05-003

Identifier Type: -

Identifier Source: org_study_id