CataractNCT00825747
Evaluation of Seelens AF, an Aspheric Intra-ocular Lens
A study testing SeeLens AF intra-ocular lens in people with Cataract, run by Hanita Lenses at 2 sites in Israel.
Trial summary
Senile cataract is managed by cataract extraction and intra-ocular lens (IOL) implantation. The purpose of this study is to evaluate the safety and efficacy of the SeeLens AF, an acrylic hydrophilic aspheric IOL. This lens was designed to reduce vision aberrations and secondary cataract formation rate. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cataract
- What is being tested?
- SeeLens AF intra-ocular lens
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 2 sitesIsrael
- Study dates
- Jan 2009to Jan 2010
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Senile Cataract
- Age >18 years
- Cataract extraction using phacoemulsification
- Corneal incision less than 1.5 mm
Who cannot join
- Allergy/sensitivity to eye drops used during and after cataract surgery
- Amblyopia/ strabismus
- Ocular disease, other than cataract, diminishing visual acuity, such as corneal opacity, advanced glaucoma, diabetic retinopathy, exudative or moderate to severe non-exudative age-related macular degeneration, uveitis.
- previous ocular surgery or ocular trauma in the investigated eye
- Ocular anomaly, such as microphthalmos
- Keratometry values less than 40 diopters or more than 47 diopters.
Show all 10Show fewer
- Ocular axial length less than 21.0 mm or longer than 25.0 mm
- Intra-operative complications prior to intraocular lens implantation, such as tear of the posterior capsule.
- posterior capsular scar
- visual acuity in the fellow eye less than 20/200
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Soroka University Medical Center
Beersheba, 84101
Meir Medical Center
Kfar Saba, 44410
About this study
Official title: Clinical Evaluation of the Aspheric SeeLens AF Intra-ocular Lens.
Senile cataract is managed by cataract extraction and intra-ocular lens (IOL) implantation. The purpose of this study is to evaluate the safety and efficacy of the SeeLens AF, an acrylic hydrophilic aspheric IOL. This lens was designed to reduce vision aberrations and secondary cataract formation rate.
Preoperative evaluation: Best corrected visual acuity, refraction, comprehensive slit lamp examination and biometry.
Read more
Surgical procedure: Cataract surgery using a clear corneal incision (1.8mm to2.4mm), phacoemulsification and implantation of the SeeLens AF to the capsular bag. IOL implantation parameters will be evaluated by the surgeon.
Postoperative follow up: Best corrected visual acuity, uncorrected visual acuity, refraction and comprehensive slit lamp examinations up to 3 months after surgery.
- Conditions
- Cataract
- Being tested
- SeeLens AF intra-ocular lens
- Keywords
- Cataract, Cataract surgery, intraocular lens, Aspheric lens
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeeLens AF intra-ocular lensDevice
Also called aspheric SeeLens
the SeeLens AF is an acrylic hydrophilic C shaped haptics intra-ocular lens, designed for implantation in the lenticular capsular bag or the sulcus during cataract surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity 3 months after SeeLens AF implantation
Measured: 3 months
Secondary outcomes (3)
Complications related to SeeLens AF implantation during cataract surgery.
Measured: 3 months
Postoperative severe intra-ocular inflammation or infection
Measured: 3 months
Prediction of ocular refraction after cataract surgery with Seelens AF implantation
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2010
- Study completionJan 2010
Why it stopped: study was closed
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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanita Lenses
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Yokrat Ton, MD, Principal investigator, Meir Medical Center, affiliated with Tel-Aviv University, Tel-Aviv, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00825747
- Sponsor's protocol ID
- SeeLensAF 65
- Status last verified
- Apr 2021
- First submitted
- 18 Jan 2009
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Aspheric SeeLens AF Intra-ocular Lens.
- ClinicalTrials.gov ID
- NCT00825747
- Acronym / sponsor ID
- SeeLensAF 65
- Conditions
- Cataract
- Keywords
- Cataract, Cataract surgery, intraocular lens, Aspheric lens
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study was closed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hanita LensesIndustry (pharma, biotech, devices)
- Study start
- Jan 2009 (actual)
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 21 Jan 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.
Senile cataract is managed by cataract extraction and intra-ocular lens (IOL) implantation. The purpose of this study is to evaluate the safety and efficacy of the SeeLens AF, an acrylic hydrophilic aspheric IOL. This lens was designed to reduce vision aberrations and secondary cataract formation rate.
Preoperative evaluation: Best corrected visual acuity, refraction, comprehensive slit lamp examination and biometry.
Surgical procedure: Cataract surgery using a clear corneal incision (1.8mm to2.4mm), phacoemulsification and implantation of the SeeLens AF to the capsular bag. IOL implantation parameters will be evaluated by the surgeon.
Postoperative follow up: Best corrected visual acuity, uncorrected visual acuity, refraction and comprehensive slit lamp examinations up to 3 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Senile Cataract
- Age >18 years
- Cataract extraction using phacoemulsification
- Corneal incision less than 1.5 mm
Key exclusion criteria (10 listed)
- Allergy/sensitivity to eye drops used during and after cataract surgery
- Amblyopia/ strabismus
- Ocular disease, other than cataract, diminishing visual acuity, such as corneal opacity, advanced glaucoma, diabetic retinopathy, exudative or moderate to severe non-exudative age-related macular degeneration, uveitis.
- previous ocular surgery or ocular trauma in the investigated eye
- Ocular anomaly, such as microphthalmos
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 |
|---|---|---|
| SeeLens AF intra-ocular lensAlso: aspheric SeeLensthe SeeLens AF is an acrylic hydrophilic C shaped haptics intra-ocular lens, designed for implantation in the lenticular capsular bag or the sulcus during cataract surgery. | Device | – |
Primary outcome
Best corrected visual acuity 3 months after SeeLens AF implantation
Time frame: 3 months
3 secondary outcomes
Complications related to SeeLens AF implantation during cataract surgery.
Time frame: 3 months
Postoperative severe intra-ocular inflammation or infection
Time frame: 3 months
Prediction of ocular refraction after cataract surgery with Seelens AF implantation
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
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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.
Yokrat Ton, MD principal investigator
Meir Medical Center, affiliated with Tel-Aviv University, Tel-Aviv, Israel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SeeLens AF intra-ocular lens in people with Cataract, run by Hanita Lenses at 2 sites in Israel.
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 4 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: withdrawn, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Best corrected visual acuity 3 months after SeeLens AF implantation (time frame: 3 months). 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 13 Apr 2021.