Back to resultsEvaluation of Seelens AF, an Aspheric Intra-ocular Lens
Primary Purpose
Cataract
Status
Withdrawn
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
SeeLens AF intra-ocular lens
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring Cataract, Cataract surgery, intraocular lens, Aspheric lens
Eligibility Criteria
Inclusion Criteria:
- Senile Cataract
- Age >18 years
- Cataract extraction using phacoemulsification
- Corneal incision less than 1.5 mm
Exclusion Criteria:
- 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.
- 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
Sites / Locations
- Soroka University Medical Center
- Meir Medical Center
Outcomes
Primary Outcome Measures
Best corrected visual acuity 3 months after SeeLens AF implantation
Secondary Outcome Measures
Complications related to SeeLens AF implantation during cataract surgery.
Postoperative severe intra-ocular inflammation or infection
Prediction of ocular refraction after cataract surgery with Seelens AF implantation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00825747
Brief Title
Evaluation of Seelens AF, an Aspheric Intra-ocular Lens
Official Title
Clinical Evaluation of the Aspheric SeeLens AF Intra-ocular Lens.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Withdrawn
Why Stopped
study was closed
Study Start Date
January 2009 (Actual)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hanita Lenses
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Cataract, Cataract surgery, intraocular lens, Aspheric lens
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
SeeLens AF intra-ocular lens
Other Intervention Name(s)
aspheric SeeLens
Intervention Description
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.
Primary Outcome Measure Information:
Title
Best corrected visual acuity 3 months after SeeLens AF implantation
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Complications related to SeeLens AF implantation during cataract surgery.
Time Frame
3 months
Title
Postoperative severe intra-ocular inflammation or infection
Time Frame
3 months
Title
Prediction of ocular refraction after cataract surgery with Seelens AF implantation
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Senile Cataract
Age >18 years
Cataract extraction using phacoemulsification
Corneal incision less than 1.5 mm
Exclusion Criteria:
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.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yokrat Ton, MD
Organizational Affiliation
Meir Medical Center, affiliated with Tel-Aviv University, Tel-Aviv, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soroka University Medical Center
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Meir Medical Center
City
Kfar-Saba
ZIP/Postal Code
44410
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Seelens AF, an Aspheric Intra-ocular Lens
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