NCT02863159

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

August 11, 2016

Status Verified

August 1, 2016

Enrollment Period

1.3 years

First QC Date

March 8, 2016

Last Update Submit

August 8, 2016

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Treatment Group 1

ACTIVE COMPARATOR

50 qualified study patients will receive the +2.75D (ZKB00) in their dominant eye and the +3.25D (ZLB00) in their non-dominant eye.

Device: Tecnis Multifocal 1-Piece IOL

Treatment Group 2

ACTIVE COMPARATOR

50 qualified study patients will receive the +2.75D (ZKB00) in their dominant eye and the +4.00D (ZMB00) in their non-dominant eye.

Device: Tecnis Multifocal 1-Piece IOL

Interventions

Tecnis Multifocal 1-Piece IOLDEVICE

+2.75D (ZKB00), +3.25D (ZKB00), +4.00D (ZMB00)

Treatment Group 1Treatment Group 2

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dell Laser Consultants

Austin, Texas, 78746, United States

RECRUITING

Related Publications (1)

  • Dell SJ. Evaluation of Visual and Subjective Outcomes with Mix-and-Match of Three One-Piece Tecnis Multifocal IOLs of Varying Add Powers. Clin Ophthalmol. 2020 Sep 29;14:2903-2911. doi: 10.2147/OPTH.S266120. eCollection 2020.

    PMID: 33061276DERIVED

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Steven J Dell, MD

    Dell Laser Consultants

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Ciccarelli

CONTACT

512-347-0255mciccarelli@dellvision.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2016

First Posted

August 11, 2016

Study Start

August 1, 2015

Primary Completion

December 1, 2016

Study Completion

July 1, 2017

Last Updated

August 11, 2016

Record last verified: 2016-08

Locations

US(1)