Trial Outcomes & Findings for Optimizing the Assessment of Refractive Outcomes After Cataract Surgery (NCT NCT02842151)

Results Overview

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 important to determine if an automated method has any advantages over conventional manifest refraction. A-constants based on autorefraction and manifest refraction for the study eye are compared for each subject. The mean difference between the two methods cannot be greater than 0.15 D at each of the three study centers for the methods to be considered equivalent.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

162 participants

Primary outcome timeframe

Month 3 (Day 80-100) Post Study Eye Implantation

Results posted on

2019-01-08

Participant Flow

Subjects were recruited from 3 investigative sites located in Ireland (1) and the US (2).

Of the 162 enrolled, 12 subjects were exited as screen failures prior to intraocular lens (IOL) implantation. This reporting group includes all subjects with attempted implantation (150).

Participant milestones

Participant milestones
Measure	Overall Subjects implanted with ACRYSOF® IQ Monofocal IOL Model SN60WF.
Overall Study STARTED	150
Overall Study COMPLETED	148
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Overall Subjects implanted with ACRYSOF® IQ Monofocal IOL Model SN60WF.
Overall Study Adverse Event	1
Overall Study Subject moved too far away	1

Baseline Characteristics

Optimizing the Assessment of Refractive Outcomes After Cataract Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=150 Participants Subjects implanted with ACRYSOF® IQ Monofocal IOL Model SN60WF.
Age, Continuous	68.9 years STANDARD_DEVIATION 7.63 • n=5 Participants
Sex: Female, Male Female	100 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	131 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: Month 3 (Day 80-100) Post Study Eye Implantation

Population: All-Implanted Analysis Set with non-missing data

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 important to determine if an automated method has any advantages over conventional manifest refraction. A-constants based on autorefraction and manifest refraction for the study eye are compared for each subject. The mean difference between the two methods cannot be greater than 0.15 D at each of the three study centers for the methods to be considered equivalent.

Outcome measures

Outcome measures
Measure	Manifest Refraction n=147 Eyes Standard manifest refraction assessed with an ETDRS chart using a phoropter	Autorefraction n=147 Eyes Autorefraction performed by Topcon® KR-1W Wave-Front Analyzer
IOL A-constant at 3 Months at Each Site Study Site 1 (US)	119.23 unitless Standard Deviation 0.408	119.18 unitless Standard Deviation 0.493
IOL A-constant at 3 Months at Each Site Study Site 2 (US)	118.86 unitless Standard Deviation 0.601	118.93 unitless Standard Deviation 0.723
IOL A-constant at 3 Months at Each Site Study Site 3 (Ireland)	118.39 unitless Standard Deviation 3.071	118.52 unitless Standard Deviation 3.137

Adverse Events

Ocular Adverse Events

Serious events: 4 serious events

Other events: 9 other events

Deaths: 0 deaths

Non-ocular Adverse Events

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ocular Adverse Events n=150 participants at risk At risk population for ocular adverse events is included with units of eyes.	Non-ocular Adverse Events n=150 participants at risk At risk population for non-ocular adverse events is included with units of subjects.
Investigations Intraocular pressure increased	2.0% 3/150 • IOL implantation through study completion, an average of 3 months Adverse Events (AEs) were defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the clinical investigation. Safety Analysis Set	0.00% 0/150 • IOL implantation through study completion, an average of 3 months Adverse Events (AEs) were defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the clinical investigation. Safety Analysis Set
Eye disorders Cystoid macular oedema	0.67% 1/150 • IOL implantation through study completion, an average of 3 months Adverse Events (AEs) were defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the clinical investigation. Safety Analysis Set	0.00% 0/150 • IOL implantation through study completion, an average of 3 months Adverse Events (AEs) were defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the clinical investigation. Safety Analysis Set
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/150 • IOL implantation through study completion, an average of 3 months Adverse Events (AEs) were defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the clinical investigation. Safety Analysis Set	0.67% 1/150 • IOL implantation through study completion, an average of 3 months Adverse Events (AEs) were defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the clinical investigation. Safety Analysis Set
Cardiac disorders Sinus tachycardia	0.00% 0/150 • IOL implantation through study completion, an average of 3 months Adverse Events (AEs) were defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the clinical investigation. Safety Analysis Set	0.67% 1/150 • IOL implantation through study completion, an average of 3 months Adverse Events (AEs) were defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the clinical investigation. Safety Analysis Set
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/150 • IOL implantation through study completion, an average of 3 months Adverse Events (AEs) were defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the clinical investigation. Safety Analysis Set	0.67% 1/150 • IOL implantation through study completion, an average of 3 months Adverse Events (AEs) were defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the clinical investigation. Safety Analysis Set

Other adverse events

Other adverse events
Measure	Ocular Adverse Events n=150 participants at risk At risk population for ocular adverse events is included with units of eyes.	Non-ocular Adverse Events n=150 participants at risk At risk population for non-ocular adverse events is included with units of subjects.
Eye disorders Eye inflammation	6.0% 9/150 • IOL implantation through study completion, an average of 3 months Adverse Events (AEs) were defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the clinical investigation. Safety Analysis Set	0.00% 0/150 • IOL implantation through study completion, an average of 3 months Adverse Events (AEs) were defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the clinical investigation. Safety Analysis Set

Additional Information

Senior Global Brand Affairs Lead, CDMA Surgical

Alcon, A Novartis Division

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER