CataractPhase 4NCT01248572
Evaluation of Effective Lens Position With a Uniplanar Bi-aspheric IOL
A Phase 4 study testing Softec HD IOL in people with Cataract, run by Lenstec Incorporated at 3 sites in United States.
Trial summary
The primary goal of this study is to determine the effective lens position (ELP) - or location an intraocular lens (IOL) "sits" in the eye - of the Softec HD IOL. A secondary study goal is to determine if measures of the eye taken prior to surgery can reliably predict postoperative ELP. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Softec HD IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2010to Mar 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >=40 years of age, of any race and either gender
- Operable, age related cataract grade 3+ or lower in the study eye
- Able to achieve best corrected visual acuity (BCVA) 20/30 Snellen or better postoperatively in the study eye
- ≤1.0 diopter (D) of corneal astigmatism preoperatively in the study eye
- Able to achieve a dilated pupil >6.0 millimeter (mm) in the study eye
- Able to adequately visualize the lens equatorial diameter on ultrasound biomicroscopy (UBM) unit (preoperatively)
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- Desire implantation of a monofocal lenses targeted at emmetropia in the study eye
- In good general and ocular health
- Able to competently complete testing
- Willing and able to attend study visits
- Willing and able to understand and sign an informed consent
Who cannot join
- Previous intraocular surgery or laser treatment
- Severe dry eye
- Uncontrolled IOP or glaucoma
- Retinal or macular pathology (i.e. macular degeneration, proliferative diabetic retinopathy, etc.)
- History of retinal detachment
- Microphthalmia
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- Chronic severe uveitis
- Corneal decompensation
- Irregular astigmatism
- History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
- Clinically significant corneal endothelial dystrophy (e.g., Fuchs' dystrophy)
- Pseudoexfoliation syndrome
- Iris atrophy
- Pupil abnormalities (e.g., corectopia)
- Aniseikonia
- Amblyopia
- An acute or chronic disease or illness that may confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness)
- Pregnant, lactating, or planning to become pregnant during the course of the trial
- Participation in another clinical trial within 30 days of study start
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Eye Centers of Florida
Fort Myers, Florida, 33901
Barnet-Dulaney-Perkins Eye Center
Phoenix, Arizona, 85016
Harbin Clinic
Rome, Georgia, 30165
About this study
Official title: Evaluation of Lens Effective Position, Stability and Prediction With a 12mm Uniplanar, Biaspheric Intraocular Lens
The primary goal of this study is to determine the effective lens position (ELP) - or location an intraocular lens (IOL) "sits" in the eye - of the Softec HD IOL. A secondary study goal is to determine if measures of the eye taken prior to surgery can reliably predict postoperative ELP.
Read the detailed description
The primary objective of this study is to determine the effective lens position (ELP) of the study lens, and to report the stability of ELP post-operatively. Additionally, correlations of ELP to predicted postoperative lens position, capsular bag metrics, preoperative biometry and age will be statistically analyzed for determination of ELP prediction via one, or a combination of preoperative variables.
- Conditions
- Cataract
- Being tested
- Softec HD IOL
- Keywords
- Cataract, Biaspheric intraocular lens, Uniplanar intraocular lens, Effective lens position
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Softec HD IOLDevice
Posterior chamber intraocular lens intended for the replacement of the human crystalline lens following phacoemulsification cataract removal in adults over the age of 21.
| Study group | Role | What they receive |
|---|---|---|
| Softec HD IOL | Experimental | Not described Receives: Device: Softec HD IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective Lens Position
The position of the intraocular lens - defined by measurement of the aqueous-containing space between the corneal endothelium and the anterior surface of the intraocular lens - once implanted in the capsular bag.
Measured: 6 Months Postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionMar 2012
- Study completionMar 2012
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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lenstec Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01248572
- Sponsor's protocol ID
- LTHD-10-03
- Status last verified
- Mar 2014
- First submitted
- 24 Nov 2010
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Lens Effective Position, Stability and Prediction With a 12mm Uniplanar, Biaspheric Intraocular Lens
- ClinicalTrials.gov ID
- NCT01248572
- Acronym / sponsor ID
- LTHD-10-03
- Conditions
- Cataract
- Keywords
- Cataract, Biaspheric intraocular lens, Uniplanar intraocular lens, Effective lens position
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Lenstec IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 25 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.
The primary goal of this study is to determine the effective lens position (ELP) - or location an intraocular lens (IOL) "sits" in the eye - of the Softec HD IOL. A secondary study goal is to determine if measures of the eye taken prior to surgery can reliably predict postoperative ELP.
Detailed description
The primary objective of this study is to determine the effective lens position (ELP) of the study lens, and to report the stability of ELP post-operatively. Additionally, correlations of ELP to predicted postoperative lens position, capsular bag metrics, preoperative biometry and age will be statistically analyzed for determination of ELP prediction via one, or a combination of preoperative variables.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Softec HD IOL | Experimental | Device: Softec HD IOL |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- >=40 years of age, of any race and either gender
- Operable, age related cataract grade 3+ or lower in the study eye
- Able to achieve best corrected visual acuity (BCVA) 20/30 Snellen or better postoperatively in the study eye
- ≤1.0 diopter (D) of corneal astigmatism preoperatively in the study eye
- Able to achieve a dilated pupil >6.0 millimeter (mm) in the study eye
Key exclusion criteria (19 listed)
- Previous intraocular surgery or laser treatment
- Severe dry eye
- Uncontrolled IOP or glaucoma
- Retinal or macular pathology (i.e. macular degeneration, proliferative diabetic retinopathy, etc.)
- History of retinal detachment
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 |
|---|---|---|
| Softec HD IOLPosterior chamber intraocular lens intended for the replacement of the human crystalline lens following phacoemulsification cataract removal in adults over the age of 21. | Device | Softec HD IOL |
Primary outcome
Effective Lens Position
Time frame: 6 Months Postoperative
The position of the intraocular lens - defined by measurement of the aqueous-containing space between the corneal endothelium and the anterior surface of the intraocular lens - once implanted in the capsular bag.
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 18 Mar 2014.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Softec HD IOL in people with Cataract, run by Lenstec Incorporated at 3 sites 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 11 inclusion and 19 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 18 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 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.
What does the primary outcome measure?
Effective Lens Position (time frame: 6 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 Mar 2014.