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

This study has been completed.
Sponsor:
Information provided by:
Iladevi Cataract and IOL Research Center
ClinicalTrials.gov Identifier:
NCT00855491
First received: March 3, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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


Condition Intervention
Posterior Capsule Opacification
Procedure: Phaco

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Evaluation of Posterior Capsule Opacification in Myopic Eyes 4 Years After AcrySof Single-Piece IOL Implantation

Resource links provided by NLM:


Further study details as provided by Iladevi Cataract and IOL Research Center:

Primary Outcome Measures:
  • the percentage area of PCO with posterior capsule opacity (POCO) software [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the presence of PCO within the central 3-mm zone were noted [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: July 2003
Study Completion Date: November 2008
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1. MYOPIA
axial length > 26.00 mm
Procedure: Phaco
AcrySof Single-Piece IOL
Other Names:
  • emmetropic eyes
  • normal axial length
Active Comparator: 2. Emmetropia
emmetropic eyes- eyes with an axial length of 21.00 to 23.99 mm
Procedure: Phaco
AcrySof Single-Piece IOL
Other Names:
  • emmetropic eyes
  • normal axial length

Detailed 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.

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00855491

Locations
India
Raghudeep Eye Clinic
Ahmedabad, gUJARAT, India, 52
Sponsors and Collaborators
Iladevi Cataract and IOL Research Center
Investigators
Principal Investigator: ALPESH SHAH, MS Iladevi Cataract and IOL Research Center
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Shetal Raj, ICIRC
ClinicalTrials.gov Identifier: NCT00855491     History of Changes
Other Study ID Numbers: 03-009
Study First Received: March 3, 2009
Last Updated: March 3, 2009
Health Authority: India: Iladevi Cataract & IOL Research Centre

Keywords provided by Iladevi Cataract and IOL Research Center:
PCO
POCO

Additional relevant MeSH terms:
Capsule Opacification
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014