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Management Decision
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The purpose of this study is to compare the refractive predictability (prediction error) between the Cataract Refractive Suite (CRS) and standard manual technique at one month post-operative
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRS | Experimental | First surgical eye randomized to Cataract Refractive Suite with second surgical eye (fellow eye) assigned to standard manual technique. Second eye surgery conducted within 7-14 days of the first eye surgery. |
|
| Manual | Active Comparator | First surgical eye randomized to standard manual technique with second surgical eye (fellow eye) assigned to Cataract Refractive Suite. Second eye surgery conducted within 7-14 days of the first eye surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cataract Refractive Suite (CRS) | Device | Configuration consisting of Verion™ Image Guided System, LenSx® Laser and ORA™ System with VerifEye+™ (with or without VerifEye Lynk), combined for use in surgical pre-op planning and during cataract surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) Within 0.5 Diopter (D) of Predicted Postoperative Spherical Equivalent at Month 1 | Manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder. The sphere and cylinder values were from the manifest refraction assessment. Manifest refraction was assessed at 4 meters under photopic lighting conditions using a phoropter. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned. | Day 20-40 from second implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Dissipated Energy (CDE) | Cumulative Dissipated Energy (CDE) represents the energy dissipated of the ultrasound tip and infusion sleeve at the incision point during the removal of cataractous lens. CDE was reported on the Vision System interface and measured in percent-seconds. A lower CDE indicates that less energy was expended in the eye. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sr. Clinical Manager, GCRA | Alcon, A Novartis Division | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigative Site | Panama City | Florida | 32405 | United States | ||
| Alcon Investigative Site |
This reporting group includes all enrolled subjects (39).
Subjects were recruited from 3 investigative sites located in the United States.
| ID | Title | Description |
|---|---|---|
| FG000 | All Study Subjects | Cataract extraction surgery with either Cataract Refractive Suite (CRS) or manual technique in the study eye, defined as the eye with the worst preoperative corrected distance visual acuity (CDVA), with the alternate procedure in the fellow eye |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This analysis population includes all eyes that were randomized and for which an intraocular lens (IOL) was successfully implanted (Full Analysis Set).
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Subjects | Cataract extraction surgery with either CRS or manual technique in the study eye, defined as the eye with the worst preoperative corrected distance visual acuity (CDVA), with the alternate procedure in the fellow eye |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) Within 0.5 Diopter (D) of Predicted Postoperative Spherical Equivalent at Month 1 | Manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder. The sphere and cylinder values were from the manifest refraction assessment. Manifest refraction was assessed at 4 meters under photopic lighting conditions using a phoropter. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned. | Full Analysis Set with data available | Posted | Number | percentage of eyes | Day 20-40 from second implantation | Eyes | Eyes |
|
Surgery through study completion, an average of 1 month.
An AE was 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 investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. "At risk" population for ocular AEs is reported in units of eyes. Two subjects had only 1 eye treated (39 overall subjects, 38 eyes in each group).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Suite (Ocular) | Eyes for which the LenSx was activated and a laser cut was initiated |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal Tear | Eye disorders | MedDRA (20.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Global Brand Medical Affairs Lead, CDMA Surgical | Alcon, A Novartis Division | 1-888-451-3937 | alcon.medinfo@alcon.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 6, 2017 | Jul 18, 2018 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Apr 4, 2017 | Jul 23, 2018 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Standard manual technique | Procedure | Standard biometry for intra-ocular lens (IOL) calculation and cataract removal using phacoemulsification technique |
|
| Day 0 (operative day), each eye |
| Estimated Aspiration Fluid Used During Surgery | Aspiration fluid (amount of fluid used during the removal of the cataractous lens) was measured in milliliters (ml). A lower value indicates less fluid used during the procedure. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned. | Day 0 (operative day), each eye |
| Phaco Aspiration Time Spent During Surgery | Phaco aspiration time (the average time the surgeon took to complete the phacoemulsification) was measured in seconds. A lower value indicates that the surgeon spent less time aspirating fluid and material from the eye during surgery. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned. | Day 0 (operative day), each eye |
| Stillwater |
| Minnesota |
| 55082 |
| United States |
| Alcon Investigative Site | Hurst | Texas | 76054 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Manual |
Cataract surgery using standard manual technique |
|
|
| Secondary | Cumulative Dissipated Energy (CDE) | Cumulative Dissipated Energy (CDE) represents the energy dissipated of the ultrasound tip and infusion sleeve at the incision point during the removal of cataractous lens. CDE was reported on the Vision System interface and measured in percent-seconds. A lower CDE indicates that less energy was expended in the eye. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned. | Full Analysis Set with data available | Posted | Mean | Standard Deviation | percent-seconds | Day 0 (operative day), each eye | Eyes | Eyes |
|
|
|
| Secondary | Estimated Aspiration Fluid Used During Surgery | Aspiration fluid (amount of fluid used during the removal of the cataractous lens) was measured in milliliters (ml). A lower value indicates less fluid used during the procedure. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned. | Full Analysis Set with data available | Posted | Mean | Standard Deviation | ml | Day 0 (operative day), each eye | Eyes | Eyes |
|
|
|
| Secondary | Phaco Aspiration Time Spent During Surgery | Phaco aspiration time (the average time the surgeon took to complete the phacoemulsification) was measured in seconds. A lower value indicates that the surgeon spent less time aspirating fluid and material from the eye during surgery. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned. | Full Analysis Set with available data | Posted | Mean | Standard Deviation | seconds | Day 0 (operative day), each eye | Eyes | Eyes |
|
|
|
| 0 |
| 38 |
| 1 |
| 38 |
| 0 |
| 38 |
| EG001 | Manual (Ocular) | Eyes for which the incision was initiated using standard manual techniques | 0 | 38 | 0 | 38 | 0 | 38 |
| EG002 | Nonocular | Subjects for which cataract surgery was conducted in one or both eyes | 0 | 39 | 0 | 39 | 0 | 39 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.