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Clinical Trials/NCT05418153
NCT05418153CompletedNot Applicable

Evaluating the New Synergy IOL - First 7 Months Data From Two US Centers

Center For Sight2 sites in 1 country52 target enrollmentStarted: March 14, 2022Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
52
Locations
2
Primary Endpoint
Binocular Distance Corrected Near Visual Acuity at 40 cm Under Mesopic Conditions
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This is a single visit study to evaluate the visual outcomes and patient satisfaction of patients who were bilaterally implanted with the Tecnis Synergy IOL between June 1 and December 31, 2021 in 2 centers in USA

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Age: 18 years and older.
  • •Gender: Males and Females.
  • •Uneventful bilateral lens extraction
  • •Bilateral implantation of Synergy IOLs (toric and non-toric) by 5 anterior segment surgeons at Center For Sight (DWS, WJL, JWK, WLS, and JOD) and 1 surgeon at Carolina Eyecare Physicians (KDS) through the months of June to December
  • •Willing and able to provide written informed consent for participation in the study.
  • •Willing and able to comply with scheduled visit and study examination procedures.
  • •At least 3 months postoperative from second eye IOL implantation.
  • •Postoperative best corrected visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.

Exclusion Criteria

  • •Established ocular pathology, including: glaucoma (except glaucoma suspects), uveitis, and clinically-significant retinal pathology affecting the macula (with visual acuity worse than 20/32) and/or any other ocular findings that may, in the opinion of the investigator, affect vision.
  • •Uncontrolled diabetes.
  • •Use of any systemic or topical drug known to interfere with visual performance.
  • •Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
  • •Clinically significant corneal dystrophy.
  • •Irregular astigmatism.
  • •History of chronic intraocular inflammation.
  • •Previous intraocular surgery.
  • •Previous keratoplasty
  • •Previous refractive surgery.
  • •Severe dry eye
  • •Pupil abnormalities
  • •Any clinically significant, serious or severe medical or psychiatric condition that may interfere with the interpretation of study results.
  • •Participation in (or current participation) any ophthalmic investigational drug or ophthalmic device trial within the previous 30 days prior to the start date of this trial.
  • •Best-corrected distance visual acuity worse than 20/32 in each eye.
  • •Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
  • •Abnormal iris
  • •Patients who had a complication during cataract surgery, which could include ruptured zonules, torn capsule, or vitrectomy.

Outcomes

Primary Outcomes

Binocular Distance Corrected Near Visual Acuity at 40 cm Under Mesopic Conditions

Time Frame: Up to 1 year

Visual acuity measured at 40 cm under dim light

Binocular Distance Corrected Near Visual Acuity at 40 cm Under Photopic Conditions

Time Frame: Up to 1 year

Visual acuity measured at 40 cm

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Center For Sight
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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