CataractsPhase 2NCT00001311
Modified Intraocular Lens to Reduce Eye Inflammation After Cataract Surgery in Uveitis Patients
A Phase 2 study testing heparin-surface modified intraocular lens in people with Cataracts, run by National Eye Institute (NEI) at 1 site in United States.
Trial summary
This study will test the effectiveness of an intraocular lens treated with heparin in reducing or preventing inflammation after cataract surgery in patients with uveitis. Patients with uveitis (inflammatory eye disease) often develop cataracts (clouding of the lens of the eye) that can impair eyesight. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cataracts
- What is being tested?
- heparin-surface modified intraocular lens
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1992to Feb 2001
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Follow-up Only.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Eye Institute (NEI)
Bethesda, Maryland, 20892
About this study
Official title: Evaluation of the Efficacy of a Surface Modified Intraocular Lens in Reducing Post-Operative Inflammatory Signs Following Extracapsular Surgery in Uveitis Patients With Cataracts
This study will test the effectiveness of an intraocular lens treated with heparin in reducing or preventing inflammation after cataract surgery in patients with uveitis.
Patients with uveitis (inflammatory eye disease) often develop cataracts (clouding of the lens of the eye) that can impair eyesight. Cataracts can be removed surgically, and this is usually done when poor vision interferes with adequate daily functioning, or when the lens becomes too cloudy to evaluate the level of eye inflammation in uveitis-information needed to adjust medication dosages. After surgery, vision is corrected with special eyeglasses, contact lenses, or intraocular lenses (IOL). IOLs are small, plastic artificial lenses permanently placed inside the eye.
Read more
Patients with uveitis who require cataract surgery and whose eye inflammation has been controlled by medicine for at least 3 months may be eligible for this study. Those enrolled in the study will be randomly assigned to one of two treatment groups: one group will have a standard IOL implanted during cataract surgery; the other will receive a heparin-treated IOL.
Before surgery, patients will undergo standard preoperative tests, including chest X-ray, electrocardiogram, blood tests and urinalysis, as well as an eye examination that includes photography of the cornea, iris and retina. Additional tests and examinations to be done at the start of the study and at periodic follow-up visits for about 1 year may include: fluorescein angiography to evaluate the blood vessels of the retina; specular microscopy to examine the surface of the IOL; cell and flare measurements to evaluate inflammation, and ultrasound to examine the back of the eye.
Read the detailed description
The purpose of this project is to evaluate the ability of a heparin-surface modified intraocular lens to reduce the incidence and severity of post-operative inflammation in patients with uveitis undergoing extracapsular cataract surgery. Patients who have a history of uveitis and have been in remission on steroids and/or cyclosporine or cytotoxic agents for at least three months will be considered for this study. They will be randomized in a masked fashion to either a surface-modified lens or to a non-modified lens of similar design. The intraocular inflammation will be assessed using standardized clinical criteria, and by a laser cell flare meter at those sites using this equipment. The presence of inflammatory cells on the lens surface will be assessed using specular micrography. In an initial period, the study will only be carried out in the Clinical Center of the National Eye Institute (NEI) at the National Institutes of Health (NIH). However, in order to complete the study in a reasonable period of time, it may be expanded to include several outside centers.
- Conditions
- Cataracts
- Being tested
- heparin-surface modified intraocular lens
- Keywords
- Cell/Flare Meter, Heparin Coating, Inflammation, Laser Cell Flare Photometry, Multicentric, Polymethylmetacrylate, Specular Micrography, Specular Microscopy
- Medical subject headings
- Cataract, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heparin-surface modified intraocular lensDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startApr 1992
- Study completionFeb 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CataractsStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001311
- Sponsor's protocol ID
- 920157
- Other IDs
- 92-EI-0157
- Status last verified
- Mar 2000
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Ohara K. Biomicroscopy of surface deposits resembling foreign-body giant cells on implanted intraocular lenses. Am J Ophthalmol. 1985 Mar 15;99(3):304-11. doi: 10.1016/0002-9394(85)90360-5.
PubMed 3883790Wolter JR. Foreign body giant cells selectively covering haptics of intraocular lens implants: indicators of poor toleration? Ophthalmic Surg. 1983 Oct;14(10):839-44.
PubMed 6364004Shah SM, Spalton DJ, Smith SE. Measurement of aqueous cells and flare in normal eyes. Br J Ophthalmol. 1991 Jun;75(6):348-52. doi: 10.1136/bjo.75.6.348.
PubMed 2043578
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of a Surface Modified Intraocular Lens in Reducing Post-Operative Inflammatory Signs Following Extracapsular Surgery in Uveitis Patients With Cataracts
- ClinicalTrials.gov ID
- NCT00001311
- Acronym / sponsor ID
- 920157
- Conditions
- Cataracts
- Keywords
- Cell/Flare Meter, Heparin Coating, Inflammation, Laser Cell Flare Photometry, Multicentric, Polymethylmetacrylate, Specular Micrography, Specular Microscopy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- Apr 1992
- Study completion
- Feb 2001
- First posted
- 10 Dec 2002 (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.
This study will test the effectiveness of an intraocular lens treated with heparin in reducing or preventing inflammation after cataract surgery in patients with uveitis.
Patients with uveitis (inflammatory eye disease) often develop cataracts (clouding of the lens of the eye) that can impair eyesight. Cataracts can be removed surgically, and this is usually done when poor vision interferes with adequate daily functioning, or when the lens becomes too cloudy to evaluate the level of eye inflammation in uveitis-information needed to adjust medication dosages. After surgery, vision is corrected with special eyeglasses, contact lenses, or intraocular lenses (IOL). IOLs are small, plastic artificial lenses permanently placed inside the eye.
Patients with uveitis who require cataract surgery and whose eye inflammation has been controlled by medicine for at least 3 months may be eligible for this study. Those enrolled in the study will be randomly assigned to one of two treatment groups: one group will have a standard IOL implanted during cataract surgery; the other will receive a heparin-treated IOL.
Before surgery, patients will undergo standard preoperative tests, including chest X-ray, electrocardiogram, blood tests and urinalysis, as well as an eye examination that includes photography of the cornea, iris and retina. Additional tests and examinations to be done at the start of the study and at periodic follow-up visits for about 1 year may include: fluorescein angiography to evaluate the blood vessels of the retina; specular microscopy to examine the surface of the IOL; cell and flare measurements to evaluate inflammation, and ultrasound to examine the back of the eye.
Detailed description
The purpose of this project is to evaluate the ability of a heparin-surface modified intraocular lens to reduce the incidence and severity of post-operative inflammation in patients with uveitis undergoing extracapsular cataract surgery. Patients who have a history of uveitis and have been in remission on steroids and/or cyclosporine or cytotoxic agents for at least three months will be considered for this study. They will be randomized in a masked fashion to either a surface-modified lens or to a non-modified lens of similar design. The intraocular inflammation will be assessed using standardized clinical criteria, and by a laser cell flare meter at those sites using this equipment. The presence of inflammatory cells on the lens surface will be assessed using specular micrography. In an initial period, the study will only be carried out in the Clinical Center of the National Eye Institute (NEI) at the National Institutes of Health (NIH). However, in order to complete the study in a reasonable period of time, it may be expanded to include several outside centers.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| heparin-surface modified 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 4 Mar 2008.
- Background: PubMed 3883790Ohara K. Biomicroscopy of surface deposits resembling foreign-body giant cells on implanted intraocular lenses. Am J Ophthalmol. 1985 Mar 15;99(3):304-11. doi: 10.1016/0002-9394(85)90360-5.
- Background: PubMed 6364004Wolter JR. Foreign body giant cells selectively covering haptics of intraocular lens implants: indicators of poor toleration? Ophthalmic Surg. 1983 Oct;14(10):839-44.
- Background: PubMed 2043578Shah SM, Spalton DJ, Smith SE. Measurement of aqueous cells and flare in normal eyes. Br J Ophthalmol. 1991 Jun;75(6):348-52. doi: 10.1136/bjo.75.6.348.
Related trials for Cataracts
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing heparin-surface modified intraocular lens in people with Cataracts, run by National Eye Institute (NEI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 NCT00001311, which also lists 3 linked publications.
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 4 Mar 2008.