Posterior Capsule Opacification (PCO) With AcrySof Single-Piece IOL

Posterior Capsule Opacification Clinical Trial

Official title:

Prospective Evaluation of Posterior Capsule Opacification in Myopic Eyes 4 Years After AcrySof Single-Piece IOL Implantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00855491
• Other study ID #: 03-009
• Status: Completed
• Phase: N/A
• First received: March 3, 2009
• Last updated: March 3, 2009
• Start date: July 2003
• Est. completion date: November 2008

Study information

• Verified date: March 2009
• Source: Iladevi Cataract and IOL Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Iladevi Cataract & IOL Research Centre
• Study type: Interventional

Clinical Trial Summary

The purpose of this study what to evaluate if axial myopia might influence the development of PCO.

Description:

We sought to prospectively compare PCO in eyes with myopia in relation to axial length with PCO in eyes with normal axial length, to decipher the role of axial myopia in PCO 4 years after surgery for senile cataract.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2008
• Est. primary completion date: September 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 70 Years

Eligibility

Inclusion Criteria:

• local residency and presence of a cataract in an otherwise normal eye.

• Patients older than 50 years

• a dilated pupil after mydriasis

• Patients with retinochoroidal atrophy, retinal laser prophylaxis,

• hypertension

Exclusion Criteria:

• nondilating pupil after maximal dilation;

• pseudoexfoliation; mature, traumatic, black, or complicated cataracts;

• previous intraocular surgery;

• previous surgery for glaucoma;

• uveitis

• diabetes mellitus

• Patients who did not give consent preoperatively

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Capsule Opacification
• Posterior Capsule Opacification

Intervention

Procedure:
• Phaco
AcrySof Single-Piece IOL

Locations

Country	Name	City	State
India	Raghudeep Eye Clinic	Ahmedabad	gUJARAT

Sponsors (1)

Lead Sponsor	Collaborator
Iladevi Cataract and IOL Research Center

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the percentage area of PCO with posterior capsule opacity (POCO) software		4 years	No
Secondary	the presence of PCO within the central 3-mm zone were noted		4 years	No

External Links

•   Barman SA, Hollick EJ, Boyce JF, Spalton DJ, Uyyanonvara B, Sanguinetti G, Meacock W. Quantification of posterior capsular opacification in digital images after cataract surgery. Invest Ophthalmol Vis Sci 2000; 41:3882-3892
•   Buehl W, Findl O, Menapace R, Georgopoulos M, Rainer G, Wirtitsch M, Siegl H, Pinz A. Reproducibility of standardized retroillumination photography for quantification of posterior capsule opacification. J Cataract Refract Surg 2002; 28:265-270
•   Hayashi K, Yoshida M, Hayashi H. Posterior capsule opacification in myopic eyes. J Cataract Refract Surg 2006; 32:634-638
•   Kohnen S, Brauweiler P. First results of cataract surgery and implantation of negative power intraocular lenses in highly myopic eyes. J Cataract Refract Surg 1996; 22:416-420
•   Leydolt C, Davidovic S, Sacu S, Menapace R, Neumayer T, Prinz A, Buehl W, Findl O. Long-term effect of 1-piece and 3-piece hydrophobic acrylic intraocular lens on posterior capsule opacification: a randomized trial. Ophthalmology 2007; 114:1663-1669