A Clinical Assessment of the Full Range of Functional Vision With Three Tecnis Multifocal IOL 1-Piece Models in Bilateral Cataract Extraction

Status unconfirmed · Not applicable

Conditions studied: Cataract

In brief

The objective of this study is to evaluate the uncorrected binocular distance, intermediate, and near visual acuities, and assess patient's spectacle independence and satisfaction in individuals undergoing bilateral cataract extraction that have received two different arms of near add design IOLs of the same diffractive multifocal model.

Key facts

Study ID

NCT02863159

Run by

Dell Laser Consultants

People needed

100

Starts

2015-08-01

Expected to finish

2017-07-01

Last updated by the study team

2016-08-11

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• A patient with bilateral cataracts for which phacoemulsification extraction and a posterior multifocal IOL implantation has been planned for both eyes.
• Male or female in good general health, 21 years of age or older at the time of the pre-operative examination and willing to have surgery on their second eye within 7 to 30 days of their first eye.
• A patient must be willing to comply with study instructions, agree to make all office appointments, and complete the entire course of the study.
• A patient has the visual potential of 20/32 or better in each eye after cataract removal and IOL implantation in the judgment of the investigator.
• A patient with a preoperative corneal astigmatism of ≤ 1.5D in each eye [intraoperative management of corneal astigmatism is permissible, and may include arcuate incision(s) or LRI(s).]
• A patient has a post-operative astigmatism target of ≤ 0.5D in each eye.
• A patient with clear ocular media other than cataract in each eye.
• A patient with normal OCT of the macula in each eye or a macula judged to be normal by the investigator by clinical examination.
• A patient with naturally dilated pupil sizes of > 3.5mm, evaluated under mesopic illumination.
• A patient must be able to read, comprehend and be willing to give HIPAA and Informed Consent.

You may not qualify if…

• A patient with a known pathology that may affect visual acuity (as determined by the investigator); particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.) in either eye.
• A patient with amblyopia or strabismus.
• A patient with capsular or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome) in either eye.
• A patient with pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate as least 3.5mm under mesopic/scotopic conditions) in either eye.
• A patient with evidence of Epithelial Basement Membrane Dystrophy on slit-lamp examination in either eye.
• A patient with evidence of keratoconus or significant irregular astigmatism on pre-operative topography in either eye.
• A patient with a history of ocular trauma, or ocular surgery in either eye.
• A patient that may, or is expected to undergo surgical intervention and/or ocular laser treatment prior to or during the study period in either eye.
• A patient that had refractive surgery (LASIK, LASEK, RK, PRK, etc.) prior to cataract surgery in either eye.
• A patient with a history of wearing PMMA lenses within 6 months, gas permeable lenses within one month, or extended wear daily soft contact lenses within seven days of their scheduled surgery.
• A patient that requires the use of systemic or ocular medications that may affect vision.
• A patient with an uncontrolled acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes, immunocompromised, etc.).
• A patient with any uncontrolled systemic disease. A potential patient in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study.
• A patient currently participating or who has participated within 30 days prior to the start of this study in a drug or other investigational research study.

Where it is running

• Dell Laser Consultants — Austin, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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