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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FS Laser Surgery | Experimental | For femtosecond laser-assisted cataract surgery group (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device. If necessary, ultrasound (U/S) phacoemulsification will also be applied to facilitate removal of the crystalline lens during cataract surgery. |
|
| CCC Surgery | Active Comparator | For the continuous curvilinear capsulorhexis (CCC) group (CCC Surgery), subjects will receive the standard of care for CCC and U/S phacoemulsification surgery to facilitate removal of the crystalline lens during cataract surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FS Laser Surgery | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Deviation From Intended Capsulotomy Diameter | Capsulotomy diameter measured during surgery for both the experimental and control groups. | Day of Surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan F Batlle, MD | Laser Center | Principal Investigator |
| William W Culberston, MD | Bascom Palmer Eye Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laser Center | Santo Domingo | Dominican Republic |
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).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | FS Laser Surgery | For femtosecond laser-assisted cataract surgery (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device. FS Laser Surgery: The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery. |
| FG001 | CCC Surgery | Ultrasound (U/S) cataract surgery and continuous curvilinear capsulorhexis (CCC) CCC Surgery: Subjects will receive the standard of care for U/S cataract surgery and CCC to facilitate removal of the crystalline lens. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline analysis population consists of the 29 subjects that had 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).
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| ID | Title | Description |
|---|---|---|
| BG000 | FS Laser Surgery and CCC Surgery | Each eye underwent either:
|
| 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 | Deviation From Intended Capsulotomy Diameter | Capsulotomy diameter measured during surgery for both the experimental and control groups. | 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. | Posted | Mean | Standard Deviation | μm | Day of Surgery |
|
1 month
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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 | FS Laser Surgery | For femtosecond laser-assisted cataract surgery (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device. FS Laser Surgery: The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Secondary surgical intervention to reposition lens haptic | Eye disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated intraocular pressure | Eye disorders | Systematic Assessment |
This evaluation was performed on a relatively small number of patients; assessment of CDE should be repeated in a larger number of subjects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Luis Atiles, Manager, Clinical Research | AMO Development, LLC | 214 537-6784 | luis.atiles@amo.abbott.com |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D000069453 | Ultrasonic Waves |
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|
| CCC Surgery | Procedure | 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. |
|
|
| Day of Surgery |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Ultrasound (U/S) cataract surgery and continuous curvilinear capsulorhexis (CCC). CCC and U/S Surgery: Subjects will receive the standard of care for U/S cataract surgery and CCC to facilitate removal of the crystalline lens. |
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | CDE | Day of Surgery |
|
|
|
| 2 |
| 29 |
| 0 |
| 29 |
| EG001 | CCC Surgery | Ultrasound (U/S) cataract surgery and continuous curvilinear capsulorhexis (CCC). CCC Surgery: Subjects will receive the standard of care for U/S cataract surgery and CCC to facilitate removal of the crystalline lens. | 1 | 29 | 6 | 29 |
| Zonular dehiscence requiring anterior vitrectomy | Eye disorders | Systematic Assessment |
|
| Elevated IOP requiring treatment | Eye disorders | Systematic Assessment |
|
There is an agreement between the PI and the sponsor (or its agents) that restricts the PI's rights to publish trial results, but does not prohibit publication provided that prior written permission from the sponsor has been granted.
| D013016 |
| Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
| D055585 | Physical Phenomena |