Clinical Trial Details

Clinical Investigation of the TECNIS® Toric Intraocular Lens for patients who have previously had cataract surgery to determine the amount of postoperative astigmatism compared to preoperative astigmatism

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Trial Information

Broad Health Condition Eye

Specific Health ConditionDiseases / disorders of the eye

Trial Focus

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Anticipated date of first participant enrolment15/11/2018

Anticipated date of last participant enrolment15/11/2018

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Trial summary

The purpose of this observational study (no treatment) is to determine the amount of postoperative astigmatism compared to the preoperative astigmatism for participants implanted with TECNIS toric ZCT100 IOL. 

For eyes implanted with the TECNIS toric ZCT100, the amount of postoperative astigmatism should be lower than the amount of preoperative astigmatism. For eyes implanted with the TECNIS ZCB00, the amount of postoperative astigmatism may be unchanged compared to the amount of preoperative astigmatism. 

This trial will collect preoperative, operative, and postoperative data from the participant’s clinical records for the visits already occurred, and data for the single visit to be collected for the prospective visit.
Eligibility

Key inclusion criteria

1. Be at least 22 years of age at the time of screening
2. Be available, willing, and possess sufficient cognitive awareness to comply with procedures set forth in this protocol
3. Read, understand and sign the statement of informed consent and any additional documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing country
4. Have at least one eye for which:
a. Cataract extraction and posterior chamber IOL implantation was performed with or without Laser-Assisted Cataract Surgery at least 3 months (90 days) and no more than 18 months (540 days) prior to enrollment
b. The magnitude of the preoperative corneal astigmatism was between 0.50 and 1.50 diopters (inclusive) as measured by keratometry
c. Either the TECNIS® ZCB00 IOL or TECNIS® ZCT100 IOL was implanted
d. The IOL power was calculated using optical biometry (i.e., not ultrasound biometry or other means)
e. The postoperative best corrected distance monocular visual acuity (as measured at the 1-month postoperative visit) is 20/30 (6/9) Snellen or better
f. The ocular media is clear, with the exception of mild posterior capsular opacification which, in the opinion of the investigator, will not affect study outcomes
g. If Nd:YAG (Neodymium-doped yttrium aluminum garnet) capsulotomy has been performed or is required, the participant must be at least 1-week postoperative prior to prospective data collection.

Minimum age22 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1. Amblyopia or strabismus
2. Inability to focus or fixate for prolonged periods of time
3. Acute, chronic, or uncontrolled ocular or systemic disease (including diabetes) or condition which, in the opinion of the investigator, may affect study endpoints or result in increased risk to the participant 
4. Current use of systemic or ocular medications that in the opinion of the investigator may affect vision
5. Prior, current, or anticipated use during the course of the study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) that, in the opinion of the investigator, may confound study endpoints or increase the risk to the participant 
6. Concurrent or history (within 30 days prior to screening) of participation in any other clinical trial
7. For eligible eye(s) all of the following exclusion criteria apply:
a. Capsular or zonular abnormalities that may have affected postoperative centration or tilt of the IOL
b. Pupil abnormalities (non-reactive, tonic pupils, or abnormally shaped pupils)
c. Medical conditions (e.g., pupil atrophy) or medication that precludes the pupil from achieving at least 6mm diameter upon pharmacological dilation
d. Visually significant Epithelial Basement Membrane Dystrophy on biomicroscopy examination
e. Evidence of keratoconus or significant irregular astigmatism on measurement of corneal topography or keratometry
f. History of significant ocular trauma or ocular surgery (other than cataract extraction and IOL implantation), including refractive surgery (LASIK, LASEK, RK, PRK, limbal relaxing incisions, astigmatic keratotomy, etc.), toric IOL repositioning, or an expectation to undergo surgical intervention and/or ocular laser treatment during the study period (with the exception of Nd:YAG capsulotomy, however this must have been done at least 1 week prior to prospective data collection)
g. History of PMMA (Poly methyl methacrylate) lens wear within 6 months, gas permeable lens wear within 1 month, or extended-wear or daily soft contact lens wear within 7 days prior to the date of cataract surgery or prior to the prospective visit for this study
Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Johnson & Johnson Surgical Vision, Inc.
Primary Sponsor Address: 1700 East St. Andrew Place Santa Ana, CA 92705 USA
Primary Sponsor Country: United States of America

Trial IDACTRN12618001773224

UTNU1111-1220-4309

Contact person for information and recruitmentMs
Cheryl Harper
Johnson & Johnson Surgical Vision, Inc. 1700 E. St. Andrew Place Santa Ana, CA 92705
+1 913 396 3276

Further information iconCharper9@its.jnj.com
United States of America