NCT02842151

Optimizing the Assessment of Refractive Outcomes After Cataract Surgery

Completed NA Results posted Last updated 8 January 2019

What this trial tests

NA trial testing Manifest refraction in Cataract in 162 participants. Completed in 16 November 2017.

Timeline

21 September 2016

Primary endpoint
16 November 2017

16 November 2017

Quick facts

Lead sponsor	Alcon Research
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	single
Primary purpose	other
Enrollment	162
Start date	21 September 2016
Primary completion	16 November 2017
Estimated completion	16 November 2017

Drugs / interventions tested

• Manifest refraction
• ACRYSOF® IQ Monofocal IOL Model SN60WF
• Topcon® KR-1W Wave-Front Analyzer

Conditions studied

• Cataract — all drugs for Cataract →

Sponsor

Alcon Research — full company profile →

Who can join

22 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.

IOL A-constant at 3 Months at Each Site Primary · Month 3 (Day 80-100) Post Study Eye Implantation

The A-constant, is a type of IOL constant, that accounts for clinical variables that may affect the refractive outcome (e.g. patient factors, biometry method). It relates the power of the IOL to axial length and corneal measurements. It is specific to the design of the IOL, style, and placement within the eye. The optimization of the A-constant is fundamental to achieving the targeted refractive outcomes, offset any observed error and for ensuring high patient satisfaction following cataract surgery. Since errors/noise from refraction plays a significant role in A-constant optimization, it is

Study Site 1 (US)

Group	Value	95% CI
Manifest Refraction	119.23	± 0.408
Autorefraction	119.18	± 0.493

Study Site 2 (US)

Group	Value	95% CI
Manifest Refraction	118.86	± 0.601
Autorefraction	118.93	± 0.723

Study Site 3 (Ireland)

Group	Value	95% CI
Manifest Refraction	118.39	± 3.071
Autorefraction	118.52	± 3.137

Adverse events — posted to ClinicalTrials.gov

Time frame: IOL implantation through study completion, an average of 3 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Ocular Adverse Events

Serious: 4/150 (3%)

Deaths: 0/150

Non-ocular Adverse Events

Serious: 2/150 (1%)

Deaths: 0/150

Serious adverse events (5 terms)

Reaction	System	Ocular Adverse Events	Non-ocular Adverse Events
Intraocular pressure increased	Investigations	—	—
Cystoid macular oedema	Eye disorders	—	—
Gastrointestinal haemorrhage	Gastrointestinal disorders	—	—
Sinus tachycardia	Cardiac disorders	—	—
Spinal fracture	Injury, poisoning and procedural complications	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Ocular Adverse Events	Non-ocular Adverse Events
Eye inflammation	Eye disorders	—	—

Most-reported serious reactions: Intraocular pressure increased, Cystoid macular oedema, Gastrointestinal haemorrhage, Sinus tachycardia, Spinal fracture.

Data from ClinicalTrials.gov NCT02842151 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate current available assessments (automated vs. manual) with which manifest refraction data and biometric variables are obtained to understand if data from an automated refractor can be utilized to optimize the A-constant as well as manual subjective refraction (ie, to a clinically insignificant difference). The A-constant is the calculated number that helps the surgeon determine which IOL should be implanted in the eye during cataract surgery.

Publications & conference data

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