CataractPhase 2NCT00000119
Safety and Efficacy of a Heparin-Coated Intraocular Lens in Uveitis
A Phase 2 study testing Heparin Surface-Modified Intraocular Lens in people with Cataract and Uveitis, run by National Eye Institute (NEI) at 1 site in United States.
Trial summary
To investigate the safety and efficacy of a heparin surface-modified intraocular lens in patients with uveitis undergoing cataract surgery. To evaluate the safety and efficacy of intraocular lens implantation in patients with severe uveitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Heparin Surface-Modified Intraocular Lens
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Mar 1994to not given
- 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 18 years and older
- All sexes
- Adult, Older adult
Women and men 18 years or older with a documented history of uveitis in an eye requiring cataract surgery are eligible for the study. In all patients, the eye must be free of active inflammation for at least 3 months before surgery, with or without anti-inflammatory medications. Exclusion criteria include corneal pathology or hazy media that preclude evaluation of the intraocular lens, uncontrolled glaucoma, and diabetes mellitus. Monocular patients and patients who cannot be followed for at least 1 year are also excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health
Bethesda, Maryland, 20892-1858
About this study
To investigate the safety and efficacy of a heparin surface-modified intraocular lens in patients with uveitis undergoing cataract surgery.
To evaluate the safety and efficacy of intraocular lens implantation in patients with severe uveitis.
Read the detailed description
Patients with uveitis are at high risk for significant complications following cataract surgery with intraocular lens implantation. Complications may result from the surgery itself or may develop after surgery as a result of the intraocular lens. Complications related to intraocular lens implantation include iris adhesions to the intraocular lens, which can result in lens capture; cellular deposits on the surface of the lens that can obscure vision; and uveitis. Recent studies have identified giant cells on the anterior surface of intraocular lenses in some patients with uveitis, appearing to indicate an intraocular lens-induced inflammatory response. Some of these patients have required multiple YAG laser procedures to remove these deposits.
Modification of the surface of the intraocular lens with a layer of heparin may provide a more biocompatible surface. Preclinical studies have shown a reduction in the degree of postoperative complications with the heparin surface-modified intraocular lens compared with an unmodified lens. Although retrospective case series have examined the use of heparin surface-modified intraocular lenses in patients with uveitis, a randomized, controlled clinical trial has not been performed.
This is a randomized clinical trial examining the safety and efficacy of the heparin surface-modified intraocular lens in patients with uveitis. Eighty patients with a history of uveitis in an eye requiring cataract surgery will be randomized to receive a heparin surface-modified intraocular lens or the same model of intraocular lens without surface modification. The primary end point of the study will be the development of cellular deposits on the anterior surface of the intraocular lens 1 year after surgery. These cellular deposits will be assessed by a masked grader using standard photographs. Secondary end points will include visual acuity, intraocular inflammation, development of anterior and posterior synechiae, and corneal endothelial cell counts.
- Being tested
- Heparin Surface-Modified Intraocular Lens
- Medical subject headings
- Cataract, Uveitis
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 posted24 Sep 1999 (estimated)
- Study startMar 1994
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000119
- Sponsor's protocol ID
- NEI-15
- Status last verified
- Sep 1999
- First submitted
- 23 Sep 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of a Heparin-Coated Intraocular Lens in Uveitis
- ClinicalTrials.gov ID
- NCT00000119
- Acronym / sponsor ID
- NEI-15
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- Mar 1994
- First posted
- 24 Sep 1999 (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.
To investigate the safety and efficacy of a heparin surface-modified intraocular lens in patients with uveitis undergoing cataract surgery.
To evaluate the safety and efficacy of intraocular lens implantation in patients with severe uveitis.
Detailed description
Patients with uveitis are at high risk for significant complications following cataract surgery with intraocular lens implantation. Complications may result from the surgery itself or may develop after surgery as a result of the intraocular lens. Complications related to intraocular lens implantation include iris adhesions to the intraocular lens, which can result in lens capture; cellular deposits on the surface of the lens that can obscure vision; and uveitis. Recent studies have identified giant cells on the anterior surface of intraocular lenses in some patients with uveitis, appearing to indicate an intraocular lens-induced inflammatory response. Some of these patients have required multiple YAG laser procedures to remove these deposits.
Modification of the surface of the intraocular lens with a layer of heparin may provide a more biocompatible surface. Preclinical studies have shown a reduction in the degree of postoperative complications with the heparin surface-modified intraocular lens compared with an unmodified lens. Although retrospective case series have examined the use of heparin surface-modified intraocular lenses in patients with uveitis, a randomized, controlled clinical trial has not been performed.
This is a randomized clinical trial examining the safety and efficacy of the heparin surface-modified intraocular lens in patients with uveitis. Eighty patients with a history of uveitis in an eye requiring cataract surgery will be randomized to receive a heparin surface-modified intraocular lens or the same model of intraocular lens without surface modification. The primary end point of the study will be the development of cellular deposits on the anterior surface of the intraocular lens 1 year after surgery. These cellular deposits will be assessed by a masked grader using standard photographs. Secondary end points will include visual acuity, intraocular inflammation, development of anterior and posterior synechiae, and corneal endothelial cell counts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- 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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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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.
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 Cataract and Uveitis, 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.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 24 Jun 2005. 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?
Results are not available in the source record.
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?
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 24 Jun 2005.