N/A
Completed N=30
The Effects of Angle Kappa on Clinical Outcomes With the PanOptix Intraocular Lens
Pseudophakia
Source: ClinicalTrials.gov NCT04242875 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcomePrimary: Effect of Angle Kappa in Visual Disturbances — 4; 4; 5; 1 Participants
Summary
Angle Kappa is considered a potential factor in explaining suboptimal outcomes with intraocular lenses (IOLs), particularly multifocal IOLs. Some evidence suggests this is not the case. This study was designed to investigate correlations between angle kappa and post-surgical outcomes with a trifocal IOL.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effect of Angle Kappa in Visual Disturbances |
4; 4; 5; 1; 0; 0 | — |
| SECONDARY Satisfaction With Vision by Magnitude of Angle Kappa |
0; 1; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Subject is undergoing bilateral lens extraction with intraocular lens implantation (PanOptix lens).
- Willing and able to provide written informed consent for participation in the study
- Willing and able to comply with scheduled visits and other study procedures.
- Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 6 to 30 days between surgeries.
- Subjects who require an IOL power in the range of +6.0 D to +30.0 D only.
- Subjects who require a TFNT00 or TFNT30 to TFNT60 IOL.
- Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.
Exclusion Criteria
- Severe preoperative ocular pathology
- Subjects who require a higher toric power than the one available (TFNT60).
- Uncontrolled diabetes.
- Use of any systemic or topical drug known to interfere with visual performance.
- Contact lens use during the active treatment portion of the trial.
- Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
- Clinically significant corneal dystrophy
- History of chronic intraocular inflammation.
- History of retinal detachment.
- Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
- Previous ocular surgery.
- Severe dry eye
- Pupil abnormalities
- Anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc).
- Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or 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.
Data sourced from ClinicalTrials.gov (NCT04242875). 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.