Comparison of AC and PC Lenses After Vitreous Loss During ECCE
|First Received Date ICMJE||March 26, 2007|
|Last Updated Date||January 20, 2009|
|Start Date ICMJE||February 1992|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00453011 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Comparison of AC and PC Lenses After Vitreous Loss During ECCE|
|Official Title ICMJE||CSP #338 - Comparison of Anterior and Posterior Chamber Lens Implants After Vitreous Loss in Attempted Extracapsular Cataract Extraction|
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.
Primary Hypothesis: There is no difference in failure rate between patients receiving anterior chamber or posterior chamber intraocular lenses following vitreous loss in extracapsular cataract extraction (ECCE).
Secondary Hypothesis: None
Intervention: 1) Anterior chamber intraocular lens, 2) Posterior chamber intraocular lens.
Primary Outcome: Failure defined as best corrected visual acuity less than 20/40 one year following ECCE.
Study Abstract: Extracapsular cataract surgery with posterior chamber intraocular lens implantation is one of the most common and most successful of surgical procedures. In the United States alone approximately 1.4 million cataract extractions were performed in 1990. Of these the overwhelming majority do well. However, the principal complication, vitreous loss, occurs in about 5% of cases. It is often sight-limiting.
Placement of an intraocular lens in the presence of vitreous loss is controversial. The standard approach following anterior vitrectomy usually involves placement of an anterior chamber intraocular lens (AC IOL). However, it has been suggested that implantation of a posterior chamber intraocular lens (PC IOL) in many of these patients is not only possible, but preferable.
In this study, eligible patients were VA patients who had vitreous loss during attempted ECCE. At each occurrence of vitreous loss, the patients were randomly assigned to have an AC IOL or PC IOL. Patient recruitment was terminated early with 438 patients enrolled in 15 centers. Patients were followed to the completion of at least one-year follow-up.
An ?Index Group?of 500 patients without vitreous loss also was followed according to study protocol. These patients will be 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.
Results: More PC IOL patients (91%) achieved visual acuity of 20/40 or better at one year than AC IOL patients (79%). A highly significant difference (p=0.003). There was no significant difference between the two groups for patients' rating of vison or adverse events. Over 84% of the PC IOL patients and over 77% of the AC IOL patients rated their vision as good or better at one year as opposed to only 7% giving such ratings prior to surgery. For at least one rating period during the first year, 13.2% of the combined study patients had cystoid macular edema, 8.5% had posterior capsule opacification, 5.7% had glaucoma, and 3.7% had retinal detachment.
Conclusion: In the presence of sufficient capsular support, a PC IOL should be implanted after vitreous presentation during ECCE.
Collins JF, Krol WF, Gaster RN, Colling CL, Kirk GF, Smith TJ - A Comparison of Anterior Chamber and Posterior Chamber IOL's after Vitreous Loss during Cataract Surgery. The VA Cooperative Cataract Study. American Journal of Ophthalmology. 136:1-9, 2003
Collins JF, Krol WF, Kirk GF, Gaster, RN - The Effect of Vitreous Presentation During Extracapsular Cataract Surgery on the Postoperative Visual Acuity at One Year. American Journal of Ophthalmology. 138:536-542, 2004
Collins, JF, Gaster,RN, Krol,WF and the VA Cooperative Cataract Study Group. Outcomes in Patients Having Vitreous Presentation During Cataract Surgery Who Lack Capsular Support for a Nonsutured PC IOL. American Journal of Ophthalmology, Vol 141:71-78, 2006
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Study Arm (s)||Not Provided|
|Publications *||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. Epub 2007 Jun 7.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||February 1998|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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.
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Not Provided|
|NCT Number ICMJE||NCT00453011|
|Other Study ID Numbers ICMJE||338|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Department of Veterans Affairs|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||Department of Veterans Affairs|
|Verification Date||March 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP