CataractPhase 4NCT01249144
Visual and Refractive Outcomes After Implantation of Aspheric IOLs With Different Dioptric Increments and Manufacturing
A Phase 4 study testing Intraocular Lens (IOL) in people with Cataract, run by Lenstec Incorporated at 1 site in United States.
Trial summary
This study compares two intraocular lenses, the Softec HD and the Tecnis Z9002, used to replace the natural crystalline lens after cataract extraction. The variables compared include 1) the accuracy of targeted versus achieved refractive outcomes and 2) visual acuity outcomes three months after implantation. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Intraocular Lens (IOL)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Jan 2012
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- operable cataracts in both eyes
- require intraocular lenses (IOLs) in dioptric range from 18.0 diopters to 25.0 diopters in both eyes
- </=1 diopter (D) of regular astigmatism in both eyes
Who cannot join
- Intraocular surgery or laser treatment prior to cataract surgery
- Severe dry eye
- Presence of ocular infection
- Uncontrolled intraocular pressure (IOP) or glaucoma preventing a postoperative best corrected visual acuity (BCVA) of 20/25 Snellen or better
- Retinal or macular pathology preventing a postoperative BCVA of 20/25 Snellen or better
- History of retinal detachment
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- Corneal decompensation
- History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
- Clinically significant corneal endothelial dystrophy (e.g., Fuchs' dystrophy)
- Amblyopia preventing a postoperative BCVA of 20/25 Snellen or better
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Luke's Cataract & Laser Institute
Tarpon Springs, Florida, 34689
About this study
Official title: A Randomized Fellow-eye Controlled Clinical Trial to Compare the Visual and Refractive Outcomes Between Two Aspheric IOLs With Different Dioptric Increments and Manufacturing Tolerances in Patients Undergoing Bilateral Cataract Surgery
This study compares two intraocular lenses, the Softec HD and the Tecnis Z9002, used to replace the natural crystalline lens after cataract extraction. The variables compared include 1) the accuracy of targeted versus achieved refractive outcomes and 2) visual acuity outcomes three months after implantation.
- Conditions
- Cataract
- Being tested
- Intraocular Lens (IOL)
- Keywords
- Intraocular Lens (IOL), Quarter Diopter, Biaspheric
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraocular Lens (IOL)Device
Device for implantation in the capsular bag of the eye for visual correction of aphakia following cataract surgery.
| Study group | Role | What they receive |
|---|---|---|
| Tecnis Z9002 Intraocular Lens (IOL) | Active comparator | Not described Receives: Device: Intraocular Lens (IOL) |
| Softec HD Intraocular Lens (IOL) | Active comparator | Not described Receives: Device: Intraocular Lens (IOL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target versus Achieved Refraction
Measured: 3 Months Postoperative
Secondary outcomes (1)
Uncorrected Visual Acuity
Measured: 3 Months Postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: Sponsor stopped study to re-design trial
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lenstec Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- J. Pitzer Gills, III, MD, Principal investigator, St. Luke's Cataract and Laser Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01249144
- Sponsor's protocol ID
- LTHD-10-05
- Status last verified
- Mar 2014
- First submitted
- 24 Nov 2010
- Last updated
- 18 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Fellow-eye Controlled Clinical Trial to Compare the Visual and Refractive Outcomes Between Two Aspheric IOLs With Different Dioptric Increments and Manufacturing Tolerances in Patients Undergoing Bilateral Cataract Surgery
- ClinicalTrials.gov ID
- NCT01249144
- Acronym / sponsor ID
- LTHD-10-05
- Conditions
- Cataract
- Keywords
- Intraocular Lens (IOL), Quarter Diopter, Biaspheric
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor stopped study to re-design trial
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Lenstec IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 29 Nov 2010 (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 compares two intraocular lenses, the Softec HD and the Tecnis Z9002, used to replace the natural crystalline lens after cataract extraction. The variables compared include 1) the accuracy of targeted versus achieved refractive outcomes and 2) visual acuity outcomes three months after implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tecnis Z9002 Intraocular Lens (IOL) | Active comparator | Device: Intraocular Lens (IOL) |
| Softec HD Intraocular Lens (IOL) | Active comparator | Device: Intraocular Lens (IOL) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- operable cataracts in both eyes
- require intraocular lenses (IOLs) in dioptric range from 18.0 diopters to 25.0 diopters in both eyes
- </=1 diopter (D) of regular astigmatism in both eyes
Key exclusion criteria (10 listed)
- Intraocular surgery or laser treatment prior to cataract surgery
- Severe dry eye
- Presence of ocular infection
- Uncontrolled intraocular pressure (IOP) or glaucoma preventing a postoperative best corrected visual acuity (BCVA) of 20/25 Snellen or better
- Retinal or macular pathology preventing a postoperative BCVA of 20/25 Snellen or better
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 (IOL)Device for implantation in the capsular bag of the eye for visual correction of aphakia following cataract surgery. | Device | Softec HD Intraocular Lens (IOL), Tecnis Z9002 Intraocular Lens (IOL) |
Primary outcome
Target versus Achieved Refraction
Time frame: 3 Months Postoperative
1 secondary outcome
Uncorrected Visual Acuity
Time frame: 3 Months Postoperative
Results and safety
The study was stopped early (reason given: Sponsor stopped study to re-design trial). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
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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.
J. Pitzer Gills, III, MD principal investigator
St. Luke's Cataract and Laser Institute
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 (IOL) in people with Cataract, run by Lenstec Incorporated 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?
The sponsor lists 3 inclusion and 10 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: stopped early, as of the sponsor's last update on 18 Oct 2018. 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 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 was stopped early (reason given: Sponsor stopped study to re-design trial). 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.
What does the primary outcome measure?
Target versus Achieved Refraction (time frame: 3 Months Postoperative). It is what the study was designed to measure, not a finding.
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 18 Oct 2018.