Posterior Capsule Opacification (PCO) With Single Piece Hydrophobic Versus Hydrophillic Intraocular Lens (IOL)

Iladevi Cataract and IOL Research Center

Status and phase: Completed; Phase 4

Conditions: Posterior Capsule Opacification

Treatments: Procedure: Phacoemulsification

Study type: Interventional

Funder types: Other

Identifiers

NCT01125345

06-009

Details and patient eligibility

About

The purpose of the study was to compare the postoperative PCO results of the single-piece hydrophobic Acrylic IOLs versus the newer generation single-piece hydrophilic Acrylic IOLs in patients undergoing bilateral cataract surgery.

Full description

Amongst several surgical techniques and IOL technology that influence the opacification of the posterior capsule, the role of IOL material and optic design remain crucial in determining its development. The single-piece Acrylic IOLs with a hydrophobic surface have been widely used in practice. The single-piece Acrylic IOLs with a hydrophilic surface became commercially available more recently. Although there is a study that compared the single piece hydrophobic and the single piece hydrophilic IOL, it was conducted on the older generation of the hydrophilic IOL. Moreover, experimental and clinical study has been performed to evaluate the posterior capsule opacification between the Hydrophilic acrylic IOL with a sharp optic edge design excluding the optic-haptic junction, versus the newer generation hydrophilic IOL design which has an improved 360-degree sharp edge, with results favouring the latter design. There is little data that compares the single-piece Acrylic IOLs with a hydrophobic surface to the newer generation single-piece Acrylic IOLs with a hydrophilic surface. Because the IOL characteristics play a crucial role to prevent posterior capsule opacification (PCO), it is of clinical importance, as well as investigational interest to assess the PCO following implantation of these IOLs. We conducted a prospective, randomised, intra-individual study to compare the 3 year postoperative PCO results of the single-piece hydrophobic Acrylic IOLs versus the newer generation single-piece hydrophilic Acrylic IOLs in patients undergoing bilateral cataract surgery.

Enrollment: 60 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• bilateral senile surgery
• age ranged from 53 to 78 years
• pupil mydriasis > 7 mm
• No history of previous ocular surgery
• gave consent for followup examination

Exclusion criteria

• coexisting ocular morbidities
• diabetes mellitus

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

60 participants in 3 patient groups

Hydrophobic IOL

Experimental group

Description:

The single piece Acrysof hydrophobic IOL model- SN60WF

Treatment:

Procedure: Phacoemulsification

Hydrophilic IOL

Active Comparator group

Description:

Rayner Intraocular Lenses Ltd., England, Model C-flex 570C

Treatment:

Procedure: Phacoemulsification

Hydrophillic IOL

Active Comparator group

Description:

Bausch and Lomb ltd, model Akreos Adapt

Treatment:

Procedure: Phacoemulsification