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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01820065
Enrollment
390
Registered
2013-03-28
Start date
2005-06-30
Completion date
2011-10-31
Last updated
2013-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posterior Capsule Opacification After Phacoemulsification and IOL Implantation

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.

Interventions

PROCEDURECataract surgery with IOL implantation

Phacoemulsification with implantation of single piece Acrysof IOL

Sponsors

Iladevi Cataract and IOL Research Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Posterior Capsule Opacification5 years followupEvaluation of PCO (EPCO) scores in the area of the intraocular lens (IOL) optic and in the central 3mm zone at 5 years after surgery

Secondary

MeasureTime frame
EPCO Score and EPCO area with total on and part on anterior capsulorhexis cover over optic5 years postoperatively

Other

MeasureTime frameDescription
Change in PCO at different followup intervalsupto 5 years postoperativelyChange in PCO observed from 1 month to 1 year, 1 year to 3 years, and 3 years to 5 years

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026