Mode
Home
Research
Clinical Trials Drug Pipeline Weekly Digests
Reference
Conditions Medications
Community
Questions
Text Size
Log in / Sign up
N/A N=188 Randomized Double-blind Treatment

Clinical Investigation of Visual Function After Bilateral Implantation of Two Presbyopia-Correcting Trifocal Intraocular Lenses (IOL)

Cataracts

Bottom Line

View on ClinicalTrials.gov: NCT02691741 ↗
Enrolled (actual)
188
Serious AEs
1.3%
Results posted
Sep 2019
Primary outcome: Primary: Least Squares Mean Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60cm) at Day 120-180 — 0.053; 0.115 logMAR

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL (Device); AT LISA® tri IOL (Device)
Age
Adult, Older Adult · 22+ yrs
Sex
All
Sponsor
Alcon Research
Primary completion
Jul 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Least Squares Mean Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60cm) at Day 120-180		 0.053; 0.115 —
SECONDARY
Least Squares Mean Binocular UCIVA (60cm) at Day 120-180		 0.053; 0.115 0.002 sig
SECONDARY
Least Squares Mean Binocular Uncorrected Distance VA (4m) at Day 120-180		 0.015; 0.004 0.455
SECONDARY
Least Squares Mean Binocular Uncorrected Near VA (40cm) at Day 120-180		 0.083; 0.133 0.003 sig
SECONDARY
Mean Photopic Binocular Defocus Curve at Day 120-180		 -0.048; -0.069; 0.016; -0.018; 0.093; 0.048 —
SECONDARY
Mean Photopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180		 1.720; 1.735; 1.860; 1.831; 1.482; 1.496 —
SECONDARY
Mean Photopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180		 1.721; 1.754; 1.790; 1.797; 1.434; 1.426 —
SECONDARY
Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180		 1.611; 1.600; 1.648; 1.682; 1.667; 1.676 —
SECONDARY
Mean Mesopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180		 1.579; 1.538; 1.642; 1.682; 1.550; 1.607 —
SECONDARY
Subject Satisfaction Recorded at Day 120-180		 95.7; 96.6; 3.2; 2.3; 1.1; 1.1 —

Summary

The purpose of this study is to clinically evaluate the visual performance of two commercially available presbyopia-correcting Trifocal IOLs.

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of bilateral cataracts with planned clear cornea cataract removal;
  • Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures;
  • Calculated lens power between 13.0 and 30.0 Diopters (D);
  • Preoperative Best-corrected distance visual acuity (BCDVA) worse than 0.20 logMAR (ie, 0.22 logMAR or worse) in at least one eye;
  • Potential postoperative BCDVA of 0.20 logMAR or better in both eyes. Note: Subjects with any pathology that could reduce visual potential should not be enrolled in this trial;
  • Preoperative regular corneal astigmatism of < 1.00 D, in both eyes;
  • Clear intraocular media other than cataract in both eyes;
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria

  • Reasonably expected to require an ocular surgical treatment at any time during the study (other than YAG capsulotomy);
  • Previous refractive surgery or planned refractive surgery procedures throughout the entire duration of participation in the clinical study (including, but not limited to LASIK, astigmatic keratotomy and limbal relaxing incisions);
  • Clinically significant corneal abnormalities including corneal dystrophy, inflammation or edema;
  • Amblyopia;
  • Previous corneal transplant;
  • Any recurrent severe anterior or posterior segment inflammation of any etiology, and/or history of any disease producing an intraocular inflammatory reaction;
  • Rubella, congenital, traumatic, or complicated cataracts;
  • Glaucoma (uncontrolled or controlled with medication);
  • Degenerative eye disorders;
  • History of or current retinal conditions or predisposition to retinal conditions, previous history of, or a predisposition to, retinal detachment or presence of diabetic retinopathy;
  • Optic nerve atrophy;
  • Expected to require retinal laser treatment;
  • Color vision deficiencies;
  • Pregnant or lactating (current or planned during the course of the study);
  • Other protocol-specified exclusion criteria may apply.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02691741). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search