Evaluation of the Safety & Effectiveness of the Bausch & Lomb AKREOS® TL Intraocular Lens
NCT ID: NCT00838045
Last Updated: 2011-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
125 participants
INTERVENTIONAL
2006-09-30
2008-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Akreos TL intraocular lens
Bausch \& Lomb Akreos TL intraocular lens
The Bausch & Lomb Akreos TL IOL (MI60) posterior chamber IOL
Surgery to implant the Bausch \& Lomb Akreos TL Intraocular Lens will be performed using standard microsurgical techniques following cataract surgery.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
The Bausch & Lomb Akreos TL IOL (MI60) posterior chamber IOL
Surgery to implant the Bausch \& Lomb Akreos TL Intraocular Lens will be performed using standard microsurgical techniques following cataract surgery.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subjects must be undergoing primary intraocular lens implantation for the correction of aphakia following continuous curvilinear anterior capsulotomy and phacoemulsification cataract extraction.
* Subjects must require a lens power from 15 to 30 diopters.
* Subjects must have a visual potential of 20/40 or better in the study eye.
Exclusion Criteria
* Subjects with any inflammation or edema (swelling) of the cornea.
* Subjects with uncontrolled glaucoma or glaucoma under current treatment in the study eye or with ocular hypertension.
* Subjects with previous retinal detachment.
* Subjects with diabetic retinopathy (proliferative or non-proliferative).
* Subjects with rubella, bilateral congenital, traumatic, or complicated cataract.
* Subjects who have had previous ocular surgery in the planned operative eye, excluding ocular adnexa surgery.
* Subjects who have already received an Akreos TL IOL in the fellow eye.
50 Years
79 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bausch & Lomb Incorporated
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Thomas Kohnen
Role: PRINCIPAL_INVESTIGATOR
Klinikum der J.W. Goethe-Universität
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Klinikum der J.W. Goethe-Universität
Frankfurt, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
451
Identifier Type: -
Identifier Source: org_study_id