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

A Long-term Evaluation of Single-piece Hydrophobic Acrylic Intraocular Lens Implantation on the Development of Posterior Capsule Opacification

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.

Study Overview

• Status: Completed
• Conditions: Posterior Capsule Opacification After Phacoemulsification and IOL Implantation
• Intervention / Treatment: Procedure: Cataract surgery with IOL implantation

• Study Type: Observational
• Enrollment (Actual): 390

Contacts and Locations

Study Locations

• India
  • Gujarat
    • Ahmedabad, Gujarat, India, 380052
      • Iladevi Cataract & IOL Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing phacoemulsification for age-related uncomplicated phacoemulsification

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients undergoing phacoemulsification; Patients undergoing phacoemulsification for age-related cataract with implantation of a single-piece Acrysof IOL (SN60AT)	Procedure: Cataract surgery with IOL implantation; Phacoemulsification with implantation of single piece Acrysof IOL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Posterior Capsule Opacification	Evaluation of PCO (EPCO) scores in the area of the intraocular lens (IOL) optic and in the central 3mm zone at 5 years after surgery	5 years followup

Secondary Outcome Measures

Outcome Measure	Time Frame
EPCO Score and EPCO area with total on and part on anterior capsulorhexis cover over optic	5 years postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PCO at different followup intervals	Change in PCO observed from 1 month to 1 year, 1 year to 3 years, and 3 years to 5 years	upto 5 years postoperatively

Collaborators and Investigators

• Sponsor: Iladevi Cataract and IOL Research Center
• Investigators: Principal Investigator: Abhay R Vasavada, MS,FRCS, Iladevi Cataract & IOL Research Centre

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion (ACTUAL): October 1, 2011
• Study Completion (ACTUAL): October 1, 2011

Study Registration Dates

• First Submitted: March 25, 2013
• First Submitted That Met QC Criteria: March 27, 2013
• First Posted (ESTIMATE): March 28, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): March 28, 2013
• Last Update Submitted That Met QC Criteria: March 27, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Capsule Opacification
• Other Study ID Numbers: 05-003