Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00453011
Status:
COMPLETED
Last Update Posted:
2015-10-20
First Post:
2007-03-26
Brief Title:
Comparison of AC and PC Lenses After Vitreous Loss During ECCE
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CSP 338 - Comparison of Anterior and Posterior Chamber Lens Implants After Vitreous Loss in Attempted Extracapsular Cataract Extraction
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objective The standard definition of failure in cataract surgery is best corrected visual acuity of less than 2040 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 eg retinal detachment cystoid macular edema uveitis glaucoma hyphema and for the primary end point of visual acuity of 2040 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
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 eg retinal detachment cystoid macular edema uveitis glaucoma hyphema and for the primary end point of visual acuity of 2040 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
Detailed Description:
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 2040 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 14 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 Groupof 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 2040 or better at one year than AC IOL patients 79 A highly significant difference p0003 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 132 of the combined study patients had cystoid macular edema 85 had posterior capsule opacification 57 had glaucoma and 37 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 IOLs after Vitreous Loss during Cataract Surgery The VA Cooperative Cataract Study American Journal of Ophthalmology 1361-9 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 138536-542 2004
Collins JF GasterRN KrolWF 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 14171-78 2006
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 2040 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 14 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 Groupof 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 2040 or better at one year than AC IOL patients 79 A highly significant difference p0003 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 132 of the combined study patients had cystoid macular edema 85 had posterior capsule opacification 57 had glaucoma and 37 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 IOLs after Vitreous Loss during Cataract Surgery The VA Cooperative Cataract Study American Journal of Ophthalmology 1361-9 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 138536-542 2004
Collins JF GasterRN KrolWF 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 14171-78 2006
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: