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

NCT01820065 | Completed

• 1 other identifier: 05-003
• Study Type: observational
• Target: 390
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• EPCO Score and EPCO area with total on and part on anterior capsulorhexis cover over optic

  5 years postoperatively

Other Outcomes (1)

• Change in PCO at different followup intervals

  upto 5 years postoperatively

Study Arms (1)

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

Interventions

Cataract surgery with IOL implantation PROCEDURE

Phacoemulsification with implantation of single piece Acrysof IOL

Patients undergoing phacoemulsification

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing phacoemulsification for age-related uncomplicated phacoemulsification

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Iladevi Cataract and IOL Research Center: lead

Study Sites (1)

Iladevi Cataract & IOL Research Centre

Ahmedabad, Gujarat, 380052, India

Location

MeSH Terms

Interventions

Cataract Extraction

Intervention Hierarchy (Ancestors)

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

Study Officials

• Abhay R Vasavada, MS, FRCS

  Iladevi Cataract & IOL Research Centre

  PRINCIPAL INVESTIGATOR

• Abhay R Vasavada, MS,FRCS

  Iladevi Cataract & IOL Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Iladevi Cataract and IOL Research Center

Study Record Dates

• First Submitted: March 25, 2013
• First Posted: March 28, 2013
• Study Start: June 1, 2005
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: March 28, 2013

Record last verified: 2013-03

Locations

IN (1)