Trial Outcomes & Findings for Contralateral Comparison of Three Excimer Laser Systems in Performing LASIK (NCT NCT00821236)

Results Overview

Visual acuity measured without glasses or contact lenses. LogMar is a method of measuring visual acuity. Generally speaking, the U.S. population is familiar with 20/20 visual acuity reference. Samples of LogMar equivalent values would be 20/20=0.0 LogMar, 20/25=0.1 LogMar, 20/16=-0.1, etc.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

40 participants

Primary outcome timeframe

1 Day

Results posted on

2013-03-01

Participant Flow

Participant milestones

Participant milestones
Measure	Lasik for Treatment of Nearsightedness WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment LADARVision 4000 excimer laser AMO/VISX CustomVue™ excimer laser treatment
Overall Study STARTED	40
Overall Study COMPLETED	37
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Lasik for Treatment of Nearsightedness WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment LADARVision 4000 excimer laser AMO/VISX CustomVue™ excimer laser treatment
Overall Study Lost to Follow-up	3

Baseline Characteristics

Contralateral Comparison of Three Excimer Laser Systems in Performing LASIK

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Wavelight n=20 Participants WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment	AMO/VISX CustomVue n=10 Participants AMO/VISX CustomVue™	LADARVision 4000 Excimer Laser n=10 Participants LADARVision 4000 excimer laser treatment	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	40 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	25 Participants n=4 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	15 Participants n=4 Participants

PRIMARY outcome

Timeframe: 1 Day

Visual acuity measured without glasses or contact lenses. LogMar is a method of measuring visual acuity. Generally speaking, the U.S. population is familiar with 20/20 visual acuity reference. Samples of LogMar equivalent values would be 20/20=0.0 LogMar, 20/25=0.1 LogMar, 20/16=-0.1, etc.

Outcome measures

Outcome measures
Measure	Wavelight n=20 Participants WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment	AMO/VISX CustomVue n=10 Participants AMO/VISX CustomVue™	LADARVision 4000 Excimer Laser n=10 Participants LADARVision 4000 excimer laser treatment
1 Day Postoperative Lasik Uncorrected Visual Acuity	-0.04 LogMar Standard Deviation 0.08	-0.05 LogMar Standard Deviation 0.06	0.06 LogMar Standard Deviation 0.16

PRIMARY outcome

Timeframe: 1 week post op

Visual acuity measured withouth glasses or contact lenses. LogMar is a method of measuring visual acuity. Generally speaking, the U.S. population is familiar with 20/20 visual acuity reference. Samples of LogMar equivalent values would be 20/20=0.0 LogMar, 20/25=0.1 LogMar, 20/16=-0.1, etc.

Outcome measures

Outcome measures
Measure	Wavelight n=20 Participants WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment	AMO/VISX CustomVue n=10 Participants AMO/VISX CustomVue™	LADARVision 4000 Excimer Laser n=10 Participants LADARVision 4000 excimer laser treatment
1 Week Postoperative Lasik Uncorrected Visual Acuity	-0.04 LogMar Standard Deviation 5.27	-0.09 LogMar Standard Deviation 2.36	-0.02 LogMar Standard Deviation 5.8

PRIMARY outcome

Timeframe: 1 Month Postoperative

Visual acuity measured without glasses or contact lenses. LogMar is a method of measuring visual acuity. Generally speaking, the U.S. population is familiar with 20/20 visual acuity reference. Samples of LogMar equivalent values would be 20/20=0.0 LogMar, 20/25=0.1 LogMar, 20/16=-0.1, etc.

Outcome measures

Outcome measures
Measure	Wavelight n=20 Participants WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment	AMO/VISX CustomVue n=10 Participants AMO/VISX CustomVue™	LADARVision 4000 Excimer Laser n=10 Participants LADARVision 4000 excimer laser treatment
1 Month Postoperative Lasik Visual Acuity	-0.1 LogMar Standard Deviation 0.09	-0.11 LogMar Standard Deviation 0.06	0.08 LogMar Standard Deviation -0.08

Adverse Events

Wavelight

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

AMO/VISX CustomVue

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

LADARVision 4000 Excimer Laser

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Brigette Ellis

Durrie Vision

Phone: 913-491-3330

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place