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N/A Completed N=453 Single-blind Treatment

Clinical Evaluation of a Small Aperture Extended Depth of Focus Intraocular Lens

Cataract · Presbyopia
Source: ClinicalTrials.gov NCT03633695 ↗
Enrolled (actual)
453
Serious AEs
2.0%
Results posted
Oct 2022
Primary outcomePrimary: Mean Binocular Photopic Uncorrected Intermediate (66 cm) Visual Acuity (UCIVA) — 0.051; 0.228 logMAR — p=<.0001

Summary

The purpose of this study is to determine the safety and effectiveness of the IC-8 IOL implanted in one eye and a monofocal or monofocal toric IOL implanted in the fellow eye in accordance with the indication.

Outcome Measures

OutcomeResultp-value
PRIMARY
Mean Binocular Photopic Uncorrected Intermediate (66 cm) Visual Acuity (UCIVA)		 0.051; 0.228 <.0001 sig
PRIMARY
Mean Binocular Photopic Uncorrected Near (40 cm) Visual Acuity (UCNVA)		 0.186; 0.377 <.0001 sig
PRIMARY
Mean Binocular Photopic Uncorrected Distance (4 m) Visual Acuity (UCDVA)		 -0.010; 0.002 <.0001 sig
PRIMARY
Mean Monocular Photopic Distance-Corrected Intermediate (66 cm) Visual Acuity (DCIVA) in IC-8™ IOL Eyes		 0.144; 0.325 <.0001 sig
PRIMARY
Mean Monocular Photopic Depth of Focus (DOF) in IC-8™ IOL Eyes		 -1.99; -1.08 —
PRIMARY
Mean Monocular Best-corrected Distance (4 m) Visual Acuity (BCDVA)		 0.009; -0.059 <.0001 sig
PRIMARY
Proportion of IC-8™ IOL Eyes Achieving Best-corrected Distance Visual Acuity (BCDVA) 0.3 logMAR or Better Compared to the Safety and Performance Endpoints (SPE) Rates		 326; 330 —
PRIMARY
Proportion of Best-Case IC-8™ IOL Eyes Achieving Best-corrected Distance Visual Acuity (BCDVA) 0.3 logMAR or Better Compared to the Safety and Performance Endpoints (SPE) Rates		 315; 318 —
PRIMARY
Rates of IC-8™ IOL Eyes With Cumulative Ocular Serious Adverse Events		 5; 4; 0; 0; 1; 0 —
PRIMARY
Rates of IC-8™ IOL Eyes With Cumulative Postoperative Ocular Adverse Events (Secondary Surgical Interventions)		 1; 1; 0; 1; 0; 0 —
PRIMARY
Rates of IC-8™ IOL Eyes With Persistent Ocular Serious Adverse Events		 0; 0; 1; 1; 2; 1 —
PRIMARY
Rates of IC-8™ IOL Eyes With IC-8™ IOL Removals		 0; 0; 1; 1 —
PRIMARY
Rates of Eyes With Postoperative Ocular Adverse Events (Other Than Secondary Surgical Intervention), Related to Device (Serious and Non-Serious Combined)		 1; 0; 0; 0; 3; 1 —
SECONDARY
Tolerance to Preoperative Corneal Astigmatism in IC-8™ IOL Eyes With BCDVA 20/25 at 3 Months		 0.085; 0.108 <.0001 sig
SECONDARY
Mean Monocular Photopic Contrast Sensitivity Without Glare		 1.935; 2.202; 1.795; 2.055; 1.308; 1.554 —
SECONDARY
Mean Monocular Photopic Contrast Sensitivity With Glare		 1.620; 1.822; 1.513; 1.747; 1.106; 1.345 —
SECONDARY
Mean Monocular Mesopic Contrast Sensitivity Without Glare		 1.385; 1.850; 1.475; 1.964; 1.217; 1.609 —
SECONDARY
Mean Monocular Mesopic Contrast Sensitivity With Glare		 1.044; 1.338; 1.201; 1.552; 1.035; 1.353 —
SECONDARY
Mean Binocular Photopic Contrast Sensitivity Without Glare		 2.233; 2.287; 2.119; 2.141; 1.689; 1.654 —
SECONDARY
Mean Binocular Photopic Contrast Sensitivity With Glare		 1.866; 1.983; 1.856; 1.891; 1.431; 1.476 —
SECONDARY
Mean Binocular Mesopic Contrast Sensitivity Without Glare		 1.936; 1.969; 2.030; 2.079; 1.688; 1.723 —
SECONDARY
Mean Binocular Mesopic Contrast Sensitivity With Glare		 1.395; 1.559; 1.602; 1.714; 1.382; 1.403 —

Eligibility Criteria

Inclusion Criteria

  • Minimum 22 years of age;
  • Able to comprehend and have signed a statement of informed consent;
  • Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits;
  • Planned crystalline lens removal by phacoemulsification, with or without femtosecond laser-assisted extraction, and posterior chamber IOL implantation in both eyes;
  • Cataractous lens changes as demonstrated by best-corrected visual acuity (BCDVA) of 20/40 or worse either with or without a glare source present;
  • Potential for postoperative BCDVA of 20/25 or better in each eye
  • Clear intraocular media, other than cataract.

Exclusion Criteria

  • Requiring an IC-8 intraocular lens outside the available spherical power range
  • Pharmacologically dilated pupil size less than 6 mm in either eye;
  • Inability to achieve stable keratometric readings for contact lens wearers
  • Irregular astigmatism in either eye;
  • Preoperative corneal astigmatism > 1.50 diopters in either eye
  • Active or recurrent anterior segment pathology
  • Presence of ocular abnormalities other than cataract as specified in the protocol
  • Diagnosis of dry eye in which patients are unable to maintain eye comfort or adequate vision even with dry eye medication;
  • Congenital cataracts;
  • Previous corneal or intraocular surgery
  • History of ocular trauma or ocular conditions expected to require retinal laser treatment or other surgical intervention;
  • Systemic conditions as specified in the protocol;
  • Patient is pregnant, plans to become pregnant, or is lactating
  • Concurrent participation or participation in any clinical trial up to 30 days prior to preoperative visit.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03633695). 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. Informational only — not medical advice.

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