Trial Outcomes & Findings for Study of the Femtosecond Laser System as Compared to Continuous Curvilinear Capsulorhexis for Cataract Surgery (NCT NCT01069172)

Results Overview

Capsulotomy diameter measured during surgery for both the experimental and control groups.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

30 participants

Primary outcome timeframe

Day of Surgery

Results posted on

2014-09-04

Participant Flow

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.

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).

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	30	30
Overall Study COMPLETED	29	30
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Study of the Femtosecond Laser System as Compared to Continuous Curvilinear Capsulorhexis for Cataract Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FS Laser Surgery and CCC Surgery n=29 Participants 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.
Age, Continuous	70.1 years STANDARD_DEVIATION 5.90 • n=93 Participants
Sex: Female, Male Female	17 Participants n=93 Participants
Sex: Female, Male Male	12 Participants n=93 Participants

PRIMARY outcome

Timeframe: 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.

Capsulotomy diameter measured during surgery for both the experimental and control groups.

Outcome measures

Outcome measures
Measure	FS Laser Surgery n=29 Participants 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.	CCC Surgery n=29 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.
Deviation From Intended Capsulotomy Diameter	26.8 μm Standard Deviation 24.6	339.1 μm Standard Deviation 248.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	FS Laser Surgery n=29 Participants 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.	CCC Surgery n=29 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.
Cumulative Dissipated Energy (CDE)	11.58 CDE Standard Deviation 8.35	18.54 CDE Standard Deviation 12.07

Adverse Events

FS Laser Surgery

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

CCC Surgery

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	FS Laser Surgery n=29 participants at risk 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.	CCC Surgery n=29 participants at risk 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.
Eye disorders Secondary surgical intervention to reposition lens haptic	3.4% 1/29 • Number of events 1 • 1 month	0.00% 0/29 • 1 month
Eye disorders Zonular dehiscence requiring anterior vitrectomy	3.4% 1/29 • Number of events 1 • 1 month	0.00% 0/29 • 1 month
Eye disorders Elevated IOP requiring treatment	0.00% 0/29 • 1 month	3.4% 1/29 • Number of events 1 • 1 month

Other adverse events

Other adverse events
Measure	FS Laser Surgery n=29 participants at risk 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.	CCC Surgery n=29 participants at risk 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.
Eye disorders Elevated intraocular pressure	0.00% 0/29 • 1 month	20.7% 6/29 • Number of events 6 • 1 month

Additional Information

Luis Atiles, Manager, Clinical Research

AMO Development, LLC

Phone: 214 537-6784

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER