Cataracts
Conditions
Brief summary
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
Interventions
DEVICECataract Refractive Suite (CRS)
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
PROCEDUREStandard manual technique
Standard biometry for intra-ocular lens (IOL) calculation and cataract removal using phacoemulsification technique
Sponsors
Alcon, a Novartis Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with bilateral cataracts; * Planned cataract surgery and implantation of ReSTOR +2.5 D multifocal intraocular lens (IOL) in both eyes; * Clear intraocular media, other than cataract, in study eye(s); * Willing and able to complete all required postoperative visits; * Able to comprehend and sign a statement of informed consent; * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Significant irregular corneal astigmatism; * History of or current severe dry eyes, retinal/uveal pathology or concurrent ocular disease; * Previous intraocular or corneal refractive surgery, corneal transplant, or retinal detachment; * Any inflammation or edema (swelling) of the cornea; * Pregnant; * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) Within 0.5 Diopter (D) of Predicted Postoperative Spherical Equivalent at Month 1 | Day 20-40 from second implantation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Dissipated Energy (CDE) | Day 0 (operative day), each eye | 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. |
| Estimated Aspiration Fluid Used During Surgery | Day 0 (operative day), each eye | 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. |
| Phaco Aspiration Time Spent During Surgery | Day 0 (operative day), each eye | 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. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from 3 investigative sites located in the United States.
Pre-assignment details
This reporting group includes all enrolled subjects (39).
Participants by arm
| Arm | Count |
|---|---|
| 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 | 39 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Study Terminated by Sponsor | 36 |
Baseline characteristics
| Characteristic | All Study Subjects |
|---|---|
| Age, Continuous | 67.7 years STANDARD_DEVIATION 7.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 38 Participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 38 | 0 / 39 |
| other Total, other adverse events | 0 / 38 | 0 / 38 | 0 / 39 |
| serious Total, serious adverse events | 1 / 38 | 0 / 38 | 0 / 39 |
Outcome results
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.
Time frame: Day 20-40 from second implantation
Population: Full Analysis Set with data available
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Suite | Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) Within 0.5 Diopter (D) of Predicted Postoperative Spherical Equivalent at Month 1 | 80.6 percentage of eyes |
| Manual | Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) Within 0.5 Diopter (D) of Predicted Postoperative Spherical Equivalent at Month 1 | 69.4 percentage of eyes |
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.
Time frame: Day 0 (operative day), each eye
Population: Full Analysis Set with data available
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suite | Cumulative Dissipated Energy (CDE) | 3.396 percent-seconds | Standard Deviation 2.462 |
| Manual | Cumulative Dissipated Energy (CDE) | 4.032 percent-seconds | Standard Deviation 2.6022 |
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.
Time frame: Day 0 (operative day), each eye
Population: Full Analysis Set with data available
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suite | Estimated Aspiration Fluid Used During Surgery | 58.6 ml | Standard Deviation 16.48 |
| Manual | Estimated Aspiration Fluid Used During Surgery | 54.0 ml | Standard Deviation 11.57 |
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.
Time frame: Day 0 (operative day), each eye
Population: Full Analysis Set with available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suite | Phaco Aspiration Time Spent During Surgery | 197.9 seconds | Standard Deviation 77.06 |
| Manual | Phaco Aspiration Time Spent During Surgery | 173.3 seconds | Standard Deviation 57.89 |