Comparison of AC and PC Lenses After Vitreous Loss During ECCE

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00453011
Recruitment Status : Completed
First Posted : March 28, 2007
Last Update Posted : October 20, 2015
Information provided by:
VA Office of Research and Development

Brief Summary:

Objective: The standard definition of failure in cataract surgery is best corrected visual acuity of less than 20/40 at one year. The specific aim of this cooperative study was to compare the failure rate for those patients with vitreous loss in whom an PC IOL is placed to the failure rate for those in whom an AC IOL is placed after vitreous loss.

Design: A total of 437 patients in 15 centers were randomized to AC or PC IOL over a 45-month period and were followed for a minimum of one year. The null hypothesis is that the rate of failure is the same in the two groups.

All patients who were about to undergo cataract surgery in the participating centers and who did not meet an exclusion criterion were eligible for the study. At the time of surgery, if there was vitreous loss, and if in the opinion of the surgeon there was sufficient capsular support for a posterior chamber lens to be placed, then the patient was randomized into one of either the anterior or posterior chamber lens groups. The patients were then followed for complications (e.g., retinal detachment, cystoid macular edema, uveitis, glaucoma, hyphema) and for the primary end point of visual acuity of 20/40 or better at one postoperative year.

An "Index Group" of about 500 patients without vitreous loss also were followed according to study protocol. These patients were compared to those in the PC and AC IOL groups with respect to outcome and baseline characteristics in order to assess the effect of vitreous loss on complication rates.

All patients were followed at annual intervals until the termination of the study. This allowed the study to obtain long-term information with regard to visual acuity and complication rates.

Condition or disease Intervention/treatment Phase
Cataract Device: posterior chamber intraocular lens Device: anterior chamber intraocular lens Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Enrollment : 1202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: CSP #338 - Comparison of Anterior and Posterior Chamber Lens Implants After Vitreous Loss in Attempted Extracapsular Cataract Extraction
Study Start Date : February 1992
Study Completion Date : February 1998

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • The principal eligibility criterion was a visually significant lens opacity resulting in a best-corrected distance visual acuity of 20/50 or worse.

Exclusion Criteria:

  • Age less than 18 years
  • Unwillingness to give informed consent
  • Unwillingness to agree to protocol follow-up
  • Visual acuity better than 20/50
  • Any other ocular disease which would preclude a final postoperative visual acuity of 20/40 or better (e.g., proliferative diabetic retinopathy, flaucoma, or Fuchs' dystrophy)
  • History of uveitis
  • Other contraindication to an IOL
  • Cataract attributable to trauma
  • Patient only had one eye with potential for useful vision
  • Any retinal thickening or definite hard exudates within one disk diameter of center of macula
  • Patient's other eye already entered into the study.

Patients could be screened for the study twice; once for each eye if they had a cataract in both. However, if the first procedure resulted in the patient being entered into the randomized study, the 5% NVP group, or the ICS group, then the second eye was not eligible for the study.

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00453011     History of Changes
Other Study ID Numbers: 338
First Posted: March 28, 2007    Key Record Dates
Last Update Posted: October 20, 2015
Last Verified: October 2015

Keywords provided by VA Office of Research and Development:
vitreous loss
intraocular lenses
Patients undergoing extracapsular cataract surgery
Vitreous loss with sufficient capsular support for an unsutured posterior chamber lens
5% random sample of patients with no vitreous loss

Additional relevant MeSH terms:
Lens Diseases
Eye Diseases