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

Cataract Clinical Trial

Official title:

A Clinical Assessment of the Full Range of Functional Vision (Distance, Intermediate, Near) With Three Tecnis Multifocal IOL 1-Piece Models [+2.75D (ZKB00), +3.25D (ZLB00), +4.00D (ZMB00)] in Subjects Undergoing Bilateral Cataract Extraction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02863159
• Other study ID #: SJDLA-2015-01
• Status: Recruiting
• Phase: N/A
• First received: March 8, 2016
• Last updated: August 8, 2016
• Start date: August 2015
• Est. completion date: July 2017

Study information

• Verified date: August 2016
• Source: Dell Laser Consultants
• Contact: Melissa Ciccarelli
• Phone: 512-347-0255
• Email: mciccarelli[@]dellvision.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This will be a multi-center, parallel comparison clinical study design with two treatment groups. One hundred (100) qualified study patients will receive a +2.75D (ZKB00) Tecnis Multifocal 1-Piece IOL in their dominant eye. Of these study patients, 50 patients will receive the +3.25D (ZLB00) Tecnis Multifocal 1-Piece IOL in their non-dominant eye and the other 50 patients will receive the +4.00D (ZMB00) Tecnis Multifocal 1-Piece IOL in their non-dominant eye. each study patient will undergo the same routine cataract extraction procedures for each eye, with the second eye scheduled to undergo cataract extraction within 7 to 30 days after the first eye. In addition, as is customary for the surgeon, each study patient will receive the same open-label pre-operative, operative and post-operative medications over the course of the study period.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Tecnis Multifocal 1-Piece IOL
+2.75D (ZKB00), +3.25D (ZKB00), +4.00D (ZMB00)

Locations

Country	Name	City	State
United States	Dell Laser Consultants	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Dell Laser Consultants	Abbott Medical Optics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurements of uncorrected and best corrected visual acuities under mesopic illumination at distance, intermediate, and near using the ETDRS chart.	Uncorrected visual acuity measured under mesopic illumination using the ETDRS chart at 4 meters, 66.7cm, and 40.0 cm. Best-corrected visual acuity measured under mesopic illumination using the ETDRS chart at 4 meters, 66.7 cm, and 40.0 cm.	90 days post-operative	No