CataractPhase 4NCT01028872
Spherical Aberration and Contrast Sensitivity Function in Eyes Implanted With Spherical and Aspheric Intraocular Lenses: A Clinical Trial
A Phase 4 study testing Intraocular lens in people with Cataract, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
Aspheric intraocular lenses can effectively reduce higher-order aberrations and improve contrast sensitivity function after cataract surgery. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Cataract
- What is being tested?
- Intraocular lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteIran
- Study dates
- Start not givento not given
- Phase
- Phase 4
- 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 55 to 75 years
- All sexes
- Adult, Older adult
Who may be able to join
- Senile cataract
Who cannot join
- Glaucoma, corneal opacity, retinal abnormality, previous history
Trial locations and contacts
1 site in 1 country.
About this study
Aspheric intraocular lenses can effectively reduce higher-order aberrations and improve contrast sensitivity function after cataract surgery.
- Conditions
- Cataract
- Being tested
- Intraocular lens
- Keywords
- higher-order aberrations, contrast sensitivity
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraocular lensDevice
Intraocular lensDevice
Intraocular lensDevice
| Study group | Role | What they receive |
|---|---|---|
| Sensar IOL | Sham comparator | Not described Receives: Device: Intraocular lens |
| Tecnis IOL | Active comparator | Not described Receives: Device: Intraocular lens |
| AcrySof IQ | Active comparator | Not described Receives: Device: Intraocular lens |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
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 4
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01028872
- Sponsor's protocol ID
- 8547
- Status last verified
- Sep 2006
- First submitted
- 8 Dec 2009
- Last updated
- 9 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spherical Aberration and Contrast Sensitivity Function in Eyes Implanted With Spherical and Aspheric Intraocular Lenses: A Clinical Trial
- ClinicalTrials.gov ID
- NCT01028872
- Acronym / sponsor ID
- 8547
- Conditions
- Cataract
- Keywords
- higher-order aberrations, contrast sensitivity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- First posted
- 9 Dec 2009 (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.
Aspheric intraocular lenses can effectively reduce higher-order aberrations and improve contrast sensitivity function after cataract surgery.
Study design
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sensar IOL | Sham comparator | Device: Intraocular lens |
| Tecnis IOL | Active comparator | Device: Intraocular lens |
| AcrySof IQ | Active comparator | Device: Intraocular lens |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Senile cataract
Key exclusion criteria (1 listed)
- Glaucoma, corneal opacity, retinal abnormality, previous history
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 |
|---|---|---|
| Intraocular lens | Device | Sensar IOL |
| Intraocular lens | Device | Tecnis IOL |
| Intraocular lens | Device | AcrySof IQ |
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 9 Dec 2009.
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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 4 study testing Intraocular lens in people with Cataract, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 1 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 9 Dec 2009. 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 Iran. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
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 9 Dec 2009.