CataractPhase 3NCT00453011
Comparison of AC and PC Lenses After Vitreous Loss During ECCE
A Phase 3 study testing posterior chamber intraocular lens and anterior chamber intraocular lens in people with Cataract, run by VA Office of Research and Development.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- posterior chamber intraocular lens and anterior chamber intraocular lens
- Type of treatment
- Medical device
- How many people
- 1,202 participants
- Where
- No sites listed yet
- Study dates
- Feb 1992to Feb 1998
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The principal eligibility criterion was a visually significant lens opacity resulting in a best-corrected distance visual acuity of 20/50 or worse.
Who cannot join
- 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
Show all 12Show fewer
- 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.
About this study
Official title: 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.
Read more
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.
Read the 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 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
- Conditions
- Cataract
- Being tested
- posterior chamber intraocular lens, anterior chamber intraocular lens
- 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
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
posterior chamber intraocular lensDevice
anterior chamber intraocular lensDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2007 (estimated)
- Study startFeb 1992
- Study completionFeb 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 1,202 participants
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00453011
- Sponsor's protocol ID
- 338
- Status last verified
- Oct 2015
- First submitted
- 26 Mar 2007
- Last updated
- 20 Oct 2015
- Results posted
- No
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. doi: 10.1016/j.ajo.2007.04.023. Epub 2007 Jun 7.
PubMed 17559787
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSP #338 - Comparison of Anterior and Posterior Chamber Lens Implants After Vitreous Loss in Attempted Extracapsular Cataract Extraction
- ClinicalTrials.gov ID
- NCT00453011
- Acronym / sponsor ID
- 338
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,202 participants
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Feb 1992
- Study completion
- Feb 1998
- First posted
- 28 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The principal eligibility criterion was a visually significant lens opacity resulting in a best-corrected distance visual acuity of 20/50 or worse.
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| posterior chamber intraocular lens | Device | – |
| anterior chamber intraocular lens | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2015.
- Derived from this study: PubMed 17559787Gaster 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing posterior chamber intraocular lens and anterior chamber intraocular lens in people with Cataract, run by VA Office of Research and Development.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00453011, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2015; AzTrials last refreshed its copy on 7 Nov 2026.