Randomized Contralateral Clinical Trial With Single-piece (SN60WF) vs. Three Piece (MA60AC) AcrySof Intraocular Lenses (IOLs) on Development of Posterior Chamber Opacification (PCO).

Alcon

Status: Completed

Conditions: Cataract

Treatments: Device: Model SN60WF; Device: Model MA60AC

Study type: Interventional

Funder types: Industry

Identifiers

NCT00758745

P-06-03

Details and patient eligibility

About

Randomized contralateral clinical trial with single piece (Model SN60WF) vs. three piece (Model MA60AC) AcrySof Intraocular Lenses (IOLs) on development of Posterior Chamber Opacifiation (PCO).

Enrollment: 81 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 50 years
• Clear cornea
• Pupil mydriasis ≥ 7mm
• In the bag Intraocular Lens (IOL)

Exclusion criteria

• Ocular pathology - uveitis, glaucoma, pseudoexfoliation syndrome (PEX), high myopia
• Previously operated eye
• Proliferative diabetic retinopathy
• Surgical complications - incomplete rhexis, post capsular rupture (PCR), zonular dialysis

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

81 participants in 2 patient groups

Model SN60WF

Active Comparator group

Description:

Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL)

Treatment:

Device: Model SN60WF

Model MA60AC

Active Comparator group

Description:

Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL)

Treatment:

Device: Model MA60AC