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A Prospective, Single-Arm Clinical Evaluation of Visual, Refractive, and Patient-Reported Outcomes Following Bilateral Implantation of the TECNIS PureSee™ Extended Depth of Focus Intraocular Lens

ConditionCataract
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40+
SponsorVance Thompson Vision

About this trial

Assess the visual, refractive, and patient-reported outcomes - including spectacle independence - of bilateral cataract surgery with implantation of the TECNIS PureSee extended depth of focus (EDOF) IOL in subjects with visually significant cataract in a real-world setting.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged ≥40 years with bilateral visually significant cataracts electing to undergo cataract surgery

Calculated IOL power within the available PureSee power range

Both eyes targeted for plano (first minus recommended) in both eyes

Preoperative corneal astigmatism ≤0.75 D for non-toric PureSee, or within the treatment range of the PureSee Toric platform

Disqualifiers

Prior intraocular or corneal refractive surgery in the operative eye(s)

Irregular corneal astigmatism, keratoconus, pellucid marginal degeneration, or other ectatic disease

Clinically significant macular pathology, advanced glaucoma with field loss, amblyopia, or any concurrent ocular condition that would limit BCVA at the discretion of the investigator

Pupil abnormalities, zonular instability, pseudoexfoliation, or any condition predisposing to intraoperative or postoperative IOL instability

Trial design

Design model

Single group

Treatments tested in this trial

  • PureSee IOL

    Device

    Bilateral implantation of the TECNIS PureSee extended depth of focus IOL

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Participants with cataracts who choose to undergo cataract surgeryExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Monocular and binocular uncorrected distance visual acuity (UCDVA) at 1-3 months postoperatively

Time frame
1 month and 3 months post cataract surgery
2

Monocular and binocular uncorrected intermediate visual acuity (UCIVA) at 66 cm

Time frame
3 months post cataract surgery
3

Patient-reported spectacle independence for distance, intermediate, and near tasks assessed via validated questionnaire (AIOLIS questionnaire)

Time frame
3 months post cataract surgery

Secondary outcomes

1

Monocular and binocular uncorrected near visual acuity (UCNVA) at 40 cm at 3 months postoperatively

Time frame
3 months post cataract surgery
2

Manifest refraction spherical equivalent (MRSE) and percentage of eyes within ±0.50 D and ±1.00 D of the refractive target

Time frame
3 months post cataract surgery
3

Rate (%) of visual disturbances using the AIOLIS validated questionnaire

Time frame
3 months post cataract surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vance Thompson Vision

Lead sponsor

Johnson & Johnson

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: