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NCT03090256

Clinical Investigation of the AcrySof® IQ PanOptix™ IOL

Completed NA Results posted Last updated 24 September 2019
What this trial tests

NA trial testing AcrySof® IQ PanOptix™ IOL in Cataract in 76 participants. Completed in 13 February 2018.

Timeline
11 April 2017
Primary endpoint
13 February 2018
13 February 2018

Quick facts

Lead sponsorAlcon Research
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment76
Start date11 April 2017
Primary completion13 February 2018
Estimated completion13 February 2018
Sites2 locations across Japan

Drugs / interventions tested

Conditions studied

Sponsor

Alcon Research — full company profile →

Who can join

20 and older, any sex, with Cataract. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Monocular Photopic Best Corrected Distance Visual Acuity (5 m) Primary · Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation

Visual acuity (VA) was tested monocularly (each eye separately) under well-lit conditions with the subject's best spectacle correction at a distance of 5 meters (m) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study.

Visit 0 preoperative: < 0.5
GroupValue95% CI
First Eye15
Second Eye5
Visit 0 preoperative: 0.5 - < 0.7
GroupValue95% CI
First Eye9
Second Eye8
Visit 0 preoperative: 0.7 - < 1.0
GroupValue95% CI
First Eye35
Second Eye34
Visit 0 preoperative: 1.0 or better
GroupValue95% CI
First Eye9
Second Eye20
Visit 1/1A: < 0.5
GroupValue95% CI
First Eye0
Second Eye0
Visit 1/1A: 0.5 - < 0.7
GroupValue95% CI
First Eye1
Second Eye0
Visit 1/1A: 0.7 - < 1.0
GroupValue95% CI
First Eye8
Second Eye8
Visit 1/1A: 1.0 or better
GroupValue95% CI
First Eye59
Second Eye59
Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm) Primary · Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation

VA was tested monocularly under well-lit conditions using a chart. Distance-corrected VA at 60 cm is the VA at 60 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study.

Visit 0 preoperative: < 0.5
GroupValue95% CI
First Eye47
Second Eye40
Visit 0 preoperative: 0.5 - < 0.7
GroupValue95% CI
First Eye18
Second Eye18
Visit 0 preoperative: 0.7 - < 1.0
GroupValue95% CI
First Eye1
Second Eye8
Visit 0 preoperative: 1.0 or better
GroupValue95% CI
First Eye2
Second Eye1
Visit 1/1A: < 0.5
GroupValue95% CI
First Eye2
Second Eye1
Visit 1/1A: 0.5 - < 0.7
GroupValue95% CI
First Eye8
Second Eye5
Visit 1/1A: 0.7 - < 1.0
GroupValue95% CI
First Eye21
Second Eye25
Visit 1/1A: 1.0 or better
GroupValue95% CI
First Eye37
Second Eye36
Monocular Photopic Distance Corrected Near Visual Acuity (40 cm) Primary · Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation

VA was tested monocularly under well-lit conditions using a chart. Distance-corrected VA at 40 cm is the VA at 40 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study.

Visit 0 preoperative: < 0.4
GroupValue95% CI
First Eye48
Second Eye40
Visit 0 preoperative: 0.4 or better
GroupValue95% CI
First Eye20
Second Eye27
Visit 1/1A: < 0.4
GroupValue95% CI
First Eye1
Second Eye0
Visit 1/1A: 0.4 or better
GroupValue95% CI
First Eye67
Second Eye67
Visit 2/2A: < 0.4
GroupValue95% CI
First Eye0
Second Eye0
Visit 2/2A: 0.4 or better
GroupValue95% CI
First Eye68
Second Eye67
Visit 3/3A: < 0.4
GroupValue95% CI
First Eye0
Second Eye0
Visit 3/3A: 0.4 or better
GroupValue95% CI
First Eye68
Second Eye67

Sponsor's own description

The purpose of this study is to evaluate the effectiveness and safety of the AcrySof® IQ PanOptix™ Intraocular Lens (IOL) Model TFNT00 when implanted to replace the natural lens following cataract removal.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Cataract

Currently open trials in the same condition.

Other Alcon Research trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03090256.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing