Optimizing the Assessment of Refractive Outcomes After Cataract Surgery
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Subjects will be implanted with ACRYSOF® IQ Monofocal IOL Model SN60WF. Standard clinical practice will be followed for pre-operative testing, IOL power estimation and IOL implantation. Only one eye will be enrolled in the study per surgeon determination. The eye will undergo both an automated and manual manifest refraction assessment at 3 months postoperative.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Manifest refraction Manifest refraction performed by autorefraction (automated) and manual procedures (standard). Subject implanted with ACRYSOF® IQ Monofocal IOL Model SN60WF. Autorefraction performed by Topcon® KR-1W Wave-Front Analyzer. |
Procedure: Manifest refraction
Manifest refraction performed by autorefraction (automated) and manual procedures (standard)
Device: ACRYSOF® IQ Monofocal IOL Model SN60WF
Monofocal IOL implanted for long-term use over the lifetime of the cataract patient
Device: Topcon® KR-1W Wave-Front Analyzer
Wavefront and topography system used to obtain autorefraction data
|
Outcome Measures
Primary Outcome Measures
- IOL A-constant at 3 Months at Each Site [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 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Able to understand and sign an Ethics Committee/Institutional Review Board approved Informed Consent;
-
Willing and able to attend all scheduled study visits as required per protocol;
-
Diagnosed with cataract in one or both eyes;
-
Planned cataract removal by phacoemulsification with implantation of a monofocal IOL; laser refractive procedures for incisions (primary and sideport), capsulorhexis and lens fragmentation are allowed;
-
Preoperative keratometric astigmatism ≤ 1.0 diopter (D);
-
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
-
Women of childbearing potential, pregnant, or breast-feeding;
-
History of ocular pathology, ocular inflammation, or ocular conditions, as specified in the protocol;
-
Previous intraocular or corneal surgery;
-
Use of systemic medications that, in the opinion of the Investigator, may confound the outcome or increase the risk of complications to the subject;
-
Any medical condition that, in the opinion of the Investigator, may confound the results of this study, prohibit the completion of the study assessments, or increase the risk for the subject;
-
Other protocol-defined exclusion criteria may apply.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Alcon Research
Investigators
- Study Director: Alcon, A Novartis Division, Alcon, A Novartis Division
Study Documents (Full-Text)
More Information
Publications
None provided.- ILQ732-I001
Study Results
Participant Flow
| Recruitment Details | Subjects were recruited from 3 investigative sites located in Ireland (1) and the US (2). |
|---|---|
| Pre-assignment Detail | 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). |
| Arm/Group Title | Overall |
|---|---|
| Arm/Group Description | Subjects implanted with ACRYSOF® IQ Monofocal IOL Model SN60WF. |
| Period Title: Overall Study | |
| STARTED | 150 |
| COMPLETED | 148 |
| NOT COMPLETED | 2 |
Baseline Characteristics
| Arm/Group Title | Overall |
|---|---|
| Arm/Group Description | Subjects implanted with ACRYSOF® IQ Monofocal IOL Model SN60WF. |
| Overall Participants | 150 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
68.9
(7.63)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
100
66.7%
|
| Male |
50
33.3%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
3
2%
|
| Not Hispanic or Latino |
131
87.3%
|
| Unknown or Not Reported |
16
10.7%
|
Outcome Measures
| Title | IOL A-constant at 3 Months at Each Site |
|---|---|
| Description | 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. |
| Time Frame | Month 3 (Day 80-100) Post Study Eye Implantation |
Outcome Measure Data
| Analysis Population Description |
|---|
| All-Implanted Analysis Set with non-missing data |
| Arm/Group Title | Manifest Refraction | Autorefraction |
|---|---|---|
| Arm/Group Description | Standard manifest refraction assessed with an ETDRS chart using a phoropter | Autorefraction performed by Topcon® KR-1W Wave-Front Analyzer |
| Measure Participants | 147 | 147 |
| Measure Eyes | 147 | 147 |
| Study Site 1 (US) |
119.23
(0.408)
|
119.18
(0.493)
|
| Study Site 2 (US) |
118.86
(0.601)
|
118.93
(0.723)
|
| Study Site 3 (Ireland) |
118.39
(3.071)
|
118.52
(3.137)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Manifest Refraction, Autorefraction |
|---|---|---|
| Comments | To demonstrate equivalency at Site 1, A-constant with manifest refraction was compared to A-constant with autorefraction. | |
| Type of Statistical Test | Equivalence | |
| Comments | Difference in A-Constant is manifest refraction minus autorefraction. The criteria for equivalence (based on paired difference t-test) was established if the bounds of the 90% two-sided confidence interval (CI) on the difference was contained within the equivalence range (-0.15, 0.15). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.05 | |
| Confidence Interval |
(2-Sided) 90% -0.03 to 0.13 |
|
| Parameter Dispersion |
Type: Standard Deviation Value: 0.346 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Manifest Refraction, Autorefraction |
|---|---|---|
| Comments | To demonstrate equivalency at Site 2, A-constant with manifest refraction was compared to A-constant with autorefraction. | |
| Type of Statistical Test | Equivalence | |
| Comments | Difference in A-Constant is manifest refraction minus autorefraction. The criteria for equivalence (based on paired difference t-test) was established if the bounds of the 90% two-sided confidence interval (CI) on the difference was contained within the equivalence range (-0.15, 0.15). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.07 | |
| Confidence Interval |
(2-Sided) 90% -0.21 to 0.07 |
|
| Parameter Dispersion |
Type: Standard Deviation Value: 0.595 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Manifest Refraction, Autorefraction |
|---|---|---|
| Comments | To demonstrate equivalency at Site 3, A-constant with manifest refraction was compared to A-constant with autorefraction. | |
| Type of Statistical Test | Equivalence | |
| Comments | Difference in A-Constant is manifest refraction minus autorefraction. The criteria for equivalence (based on paired difference t-test) was established if the bounds of the 90% two-sided confidence interval (CI) on the difference was contained within the equivalence range (-0.15, 0.15). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.13 | |
| Confidence Interval |
(2-Sided) 90% -0.22 to -0.04 |
|
| Parameter Dispersion |
Type: Standard Deviation Value: 0.340 |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | IOL implantation through study completion, an average of 3 months | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | 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 | |||
| Arm/Group Title | Ocular Adverse Events | Non-ocular Adverse Events | ||
| Arm/Group Description | At risk population for ocular adverse events is included with units of eyes. | At risk population for non-ocular adverse events is included with units of subjects. | ||
All Cause Mortality |
||||
| Ocular Adverse Events | Non-ocular Adverse Events | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/150 (0%) | 0/150 (0%) | ||
Serious Adverse Events |
||||
| Ocular Adverse Events | Non-ocular Adverse Events | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/150 (2.7%) | 2/150 (1.3%) | ||
| Cardiac disorders | ||||
| Sinus tachycardia | 0/150 (0%) | 1/150 (0.7%) | ||
| Eye disorders | ||||
| Cystoid macular oedema | 1/150 (0.7%) | 0/150 (0%) | ||
| Gastrointestinal disorders | ||||
| Gastrointestinal haemorrhage | 0/150 (0%) | 1/150 (0.7%) | ||
| Injury, poisoning and procedural complications | ||||
| Spinal fracture | 0/150 (0%) | 1/150 (0.7%) | ||
| Investigations | ||||
| Intraocular pressure increased | 3/150 (2%) | 0/150 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Ocular Adverse Events | Non-ocular Adverse Events | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 9/150 (6%) | 0/150 (0%) | ||
| Eye disorders | ||||
| Eye inflammation | 9/150 (6%) | 0/150 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
| Name/Title | Senior Global Brand Affairs Lead, CDMA Surgical |
|---|---|
| Organization | Alcon, A Novartis Division |
| Phone | 1-888-451-3937 |
| alcon.medinfo@alcon.com |
- ILQ732-I001