Cataract
Conditions
Keywords
Cataract, Surgery, cataract extraction, Optical devices, laser
Brief summary
The purpose of this study is to evaluate the safety and efficacy of the OptiMedica Femtosecond Laser System to perform surgical maneuvers used in the treatment of subjects with cataracts. The safety and efficacy will be compared to the standard surgical procedure of continuous curvilinear capsulorhexis (CCC) and ultrasonic phacoemulsification.
Interventions
DEVICEFS Laser Surgery
The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery to perform capsulotomy, lens segmentation, and lens softening, which are all part of cataract surgery when this femtosecond laser is used.
PROCEDURECCC Surgery
Subjects will receive the standard of care for CCC and U/S cataract surgery to facilitate removal of the crystalline lens. CCC is a procedure that is part of cataract surgery.
Sponsors
Abbott Medical Optics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Able and willing to comply with the treatment/follow-up schedule and requirements * Able to understand and provide written Informed Consent * ETDRS (Early Treatment of Diabetic Retinopathy Study) visual acuity equal to or worse than 20/32 (best corrected) * Age between 50 and 80 years old * Pupil dilates to at least 7 mm * Subject able to fixate * Grade 1-4 nuclear sclerotic cataract (Lens Opacities Classification System - LOCS III) * Axial length between 22 and 26 mm
Exclusion criteria
* Pregnant, intending to become pregnant during course of the study, less than 3 months postpartum or less than 6 weeks after completion of breastfeeding * Participation in a study of another device or drug within 3 months prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria * Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study or for which cataract surgery is contraindicated * Anterior chamber depth (anterior corneal surface to anterior capsule margin) less than 2.5 mm via IOL Master (Zeiss). * History of prior ocular surgery * History of ocular trauma * Co-existing ocular disease affecting vision * History or current use of alpha-1 antagonist medication (e.g., Flomax) * Known sensitivity to planned concomitant medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Deviation From Intended Capsulotomy Diameter | Day of Surgery | Capsulotomy diameter measured during surgery for both the experimental and control groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Dissipated Energy (CDE) | Day of Surgery | CDE (the amount of ultrasound energy delivered during phacoemulsification of the crystalline lens) used will be measured during surgery. CDE is a unit used for the Alcon Infinity System (the U/S phacoemulsification used in this study). It is not expressed in standard units such as watts or Joules. CDE, which accounts for the power and time of two ultrasound delivery modes (longitudinal and torsional), is calculated as follows: CDE = (Phaco time x average phaco power) + (torsional time x average torsional aptitude x 0.4) 0.4 is a factor representing the approximate reduction of heat dissipated at the incision as compared to conventional phacoemulsification. |
Countries
Dominican Republic
Participant flow
Recruitment details
Subjects served as their own control. Subjects were to have FS laser surgery in one eye (FS surgery eyes) and CCC with U/S surgery in their fellow eye (CCC surgery eyes). Assignment to one of the two surgery groups (FS or CCC) was randomized.
Pre-assignment details
30 subjects were included in the study, but one subject withdrew prior to surgery on their second eye. Baseline and outcome measure analysis was performed on the 29 subjects with both eyes enrolled. Of these 29 subjects, all had FS laser surgery in one eye (29 FS surgery eyes) and CCC with U/S surgery in their fellow eye (29 CCC surgery eyes).
Participants by arm
| Arm | Count |
|---|---|
| FS Laser Surgery and CCC Surgery Each eye underwent either:
1. Femtosecond assissisted cataract surgery (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device (the Catalys System is used for FS Laser Surgery and is an ophthalmic surgical laser system intended for use in cataract surgery).
OR
2. Ultrasound (U/S) cataract surgery and CCC (continuous curvilinear capsulorhexis), subjects will receive the standard of care for U/S cataract surgery and CCC to facilitate removal of the crystalline lens. | 29 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | FS Laser Surgery and CCC Surgery |
|---|---|
| Age, Continuous | 70.1 years STANDARD_DEVIATION 5.9 |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 29 | 6 / 29 |
| serious Total, serious adverse events | 2 / 29 | 1 / 29 |
Outcome results
Primary
Deviation From Intended Capsulotomy Diameter
Capsulotomy diameter measured during surgery for both the experimental and control groups.
Time frame: Day of Surgery
Population: 29 subjects had FS laser surgery in one eye (29 FS surgery eyes) and CCC with U/S surgery in their fellow eye (29 CCC surgery eyes). Analysis of capsulotomy size was done by eye group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FS Laser Surgery | Deviation From Intended Capsulotomy Diameter | 26.8 μm | Standard Deviation 24.6 |
| CCC Surgery | Deviation From Intended Capsulotomy Diameter | 339.1 μm | Standard Deviation 248 |
Secondary
Cumulative Dissipated Energy (CDE)
CDE (the amount of ultrasound energy delivered during phacoemulsification of the crystalline lens) used will be measured during surgery. CDE is a unit used for the Alcon Infinity System (the U/S phacoemulsification used in this study). It is not expressed in standard units such as watts or Joules. CDE, which accounts for the power and time of two ultrasound delivery modes (longitudinal and torsional), is calculated as follows: CDE = (Phaco time x average phaco power) + (torsional time x average torsional aptitude x 0.4) 0.4 is a factor representing the approximate reduction of heat dissipated at the incision as compared to conventional phacoemulsification.
Time frame: Day of Surgery
Population: 29 subjects had FS laser surgery in one eye (29 FS surgery eyes) and CCC with U/S surgery in their fellow eye (29 CCC surgery eyes). Analysis of CDE was done by eye group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FS Laser Surgery | Cumulative Dissipated Energy (CDE) | 11.58 CDE | Standard Deviation 8.35 |
| CCC Surgery | Cumulative Dissipated Energy (CDE) | 18.54 CDE | Standard Deviation 12.07 |