Comparison of AC and PC Lenses After Vitreous Loss During ECCE

NCT00453011 | Completed Phase 3

• 1 other identifier: 338
• Study Type: interventional
• Target: 1,202
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cataract

Keywords

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

Interventions

posterior chamber intraocular lens DEVICE

anterior chamber intraocular lens DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Related Publications (1)

• Gaster RN, Collins JF. The long-term effect of vitreous presentation during extracapsular cataract surgery on postoperative visual acuity. Am J Ophthalmol. 2007 Aug;144(2):186-194. doi: 10.1016/j.ajo.2007.04.023. Epub 2007 Jun 7.

  PMID: 17559787 DERIVED

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: March 26, 2007
• First Posted: March 28, 2007
• Study Start: February 1, 1992
• Study Completion: February 1, 1998
• Last Updated: October 20, 2015

Record last verified: 2015-10