Trial Outcomes & Findings for Use of the VisuMax™ Femtosecond Laser (NCT NCT01638390)

NCT ID: NCT01638390

Last Updated: 2019-03-21

Results Overview

Number of participants with a decrease in manifest refraction spherical equivalent (MRSE) to within ± 1.00 D and ± 0.50 D of the intended refractive outcome at the point at which stability is first reached. The MRSE is the amount of prescription needed to obtain your best corrected vision as compared to your preoperative best corrected vision. A minimum of 75% of eyes should have an achieved refraction within ± 1.00 D of the intended outcome, and at least 50% of eyes should be within ± 0.50 D of the intended outcome.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 357 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2019-03-21

Participant Flow

Participant milestones

Measure	Treatment of Myopia The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D. Treatment with the VisuMax™ Femtosecond Laser: The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D.
Overall Study STARTED	357
Overall Study COMPLETED	336
Overall Study NOT COMPLETED	21

Reasons for withdrawal

Measure	Treatment of Myopia The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D. Treatment with the VisuMax™ Femtosecond Laser: The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D.
Overall Study screening failures	21

Baseline Characteristics

Use of the VisuMax™ Femtosecond Laser

Baseline characteristics by cohort

Measure	Treatment of Myopia n=336 Participants The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D. Treatment with the VisuMax™ Femtosecond Laser: The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D.
Age, Continuous	33.33 years STANDARD_DEVIATION 7.9 • n=5 Participants
Sex: Female, Male Female	196 Participants n=5 Participants
Sex: Female, Male Male	140 Participants n=5 Participants
Race/Ethnicity, Customized white	309 Participants n=5 Participants
Race/Ethnicity, Customized black	10 Participants n=5 Participants
Race/Ethnicity, Customized asian	6 Participants n=5 Participants
Race/Ethnicity, Customized other	11 Participants n=5 Participants
Surgical Eye right	152 Participants n=5 Participants
Surgical Eye left	184 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: The number reflected at the 12 month visit is the effectiveness population.

Number of participants with a decrease in manifest refraction spherical equivalent (MRSE) to within ± 1.00 D and ± 0.50 D of the intended refractive outcome at the point at which stability is first reached. The MRSE is the amount of prescription needed to obtain your best corrected vision as compared to your preoperative best corrected vision. A minimum of 75% of eyes should have an achieved refraction within ± 1.00 D of the intended outcome, and at least 50% of eyes should be within ± 0.50 D of the intended outcome.

Outcome measures

Measure	Treatment of Myopia n=310 Participants The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D. Treatment with the VisuMax™ Femtosecond Laser: The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D.
Effectiveness- Predictability MRSE, Attempted vs. Achieved, ±0.50 D	291 Participants
Effectiveness- Predictability MRSE, Attempted vs. Achieved, ±1.00 D	306 Participants

PRIMARY outcome

Timeframe: 12 month

Population: The number reflected at the 12 month visit is the effectiveness population.

Number of participants with uncorrected visual acuity (UCVA) of 20/40 or better at the point of stability. .This is vision without any form of prescription. A target of 85% of participants is required.

Outcome measures

Measure	Treatment of Myopia n=310 Participants The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D. Treatment with the VisuMax™ Femtosecond Laser: The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D.
Effectiveness- Improvement in UCVA Following Treatment	309 Participants

PRIMARY outcome

Timeframe: 6 months

Number of participants with a change in postoperative refraction within 1.00 D between the 3 and 6 month visits. Stability was identified at the 6 month visit for the study.

Outcome measures

Measure	Treatment of Myopia n=327 Participants The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D. Treatment with the VisuMax™ Femtosecond Laser: The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D.
Stability Criteria- Change Between Visits Within 1.00 Diopter (D)	327 Participants

PRIMARY outcome

Timeframe: 12 months

1. Number of participants with worse than 20/40 visual acuity with a preoperative BSCVA (Best Spectacle Corrected Visual Acuity) 20/20 or better. Target is less than 1% of study participants.

2. Less than 5% of participants with BCVA loss ≥ 2 lines

Outcome measures

Measure	Treatment of Myopia n=336 Participants The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D. Treatment with the VisuMax™ Femtosecond Laser: The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D.
Safety- Preservation of Best-Spectacle Corrected Visual Acuity (BSCVA) BSCVA worse than 20/40 if 20/20 or better preopera	0 Participants
Safety- Preservation of Best-Spectacle Corrected Visual Acuity (BSCVA) Loss of ≥ 2 lines BSCVA	0 Participants

PRIMARY outcome

Timeframe: 12 months

Number of participants with an increase of astigmatism of greater than 2.00 D cylinder from the preoperative values. Target is less than 5% of participants.

Outcome measures

Measure	Treatment of Myopia n=336 Participants The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D. Treatment with the VisuMax™ Femtosecond Laser: The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D.
Safety- Induced Manifest Refractive Astigmatism	0 Participants

PRIMARY outcome

Timeframe: 12 months

Number of participants for each type of adverse event. Target of less than 1% of participants for each type of adverse event.

Outcome measures

Measure	Treatment of Myopia n=336 Participants The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D. Treatment with the VisuMax™ Femtosecond Laser: The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D.
Safety- Adverse Events Retinal vasculitis	1 Participants
Safety- Adverse Events Carcinoma in situ, conjunctival	1 Participants
Safety- Adverse Events Decrease in BSCVA of ≥ 2 lines (≥10 letters) not d	1 Participants
Safety- Adverse Events Conjunctivitis, allergic	1 Participants
Safety- Adverse Events Conjunctivitis, viral	1 Participants
Safety- Adverse Events Herpetic lid and corneal lesion	1 Participants
Safety- Adverse Events Iritis	1 Participants
Safety- Adverse Events posterior vitreous detachment	1 Participants
Safety- Adverse Events Pyogenic Granuloma	1 Participants
Safety- Adverse Events Retained tissue, small	2 Participants
Safety- Adverse Events Difficult lenticule removal with tissue damage	2 Participants

PRIMARY outcome

Timeframe: 12 months

Number of participants who increased, remained the same, and decreased in contrast sensitivity. There are 4 different frequencies (1.5, 3.0, 6.0, and 12.0) which will be tested and are more difficult to detect as the frequency number increases.

Outcome measures

Measure	Treatment of Myopia n=310 Participants The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D. Treatment with the VisuMax™ Femtosecond Laser: The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D.
Safety- Contrast Sensitivity No change	232 Participants
Safety- Contrast Sensitivity Loss at greater than or equal to 2 frequencies	5 Participants
Safety- Contrast Sensitivity Gained at greater than or equal to 2 frequencies	72 Participants

PRIMARY outcome

Timeframe: 6 months

Number of participants with a change in postoperative refraction within 0.50 D between the 3 and 6 month visits. Stability was identified at the 6 month visit for the study.

Outcome measures

Measure	Treatment of Myopia n=327 Participants The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D. Treatment with the VisuMax™ Femtosecond Laser: The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D.
Stability Criteria- Change Between Visits Within 0.50 Diopter (D)	317 Participants

SECONDARY outcome

Timeframe: 12 months

A standardized quality of vision (QoV) questionnaire was used in the study. A score is generated and was used to compare the results from baseline to the 12 month visit. Number of participants who improved, stayed the same, or worsened with regards to the frequency, severity, and bothersomeness of symptoms are reported.

Outcome measures

Measure	Treatment of Myopia n=309 Participants The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D. Treatment with the VisuMax™ Femtosecond Laser: The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D.
Safety- Patient Symptoms Frequency · worse	116 Participants
Safety- Patient Symptoms Frequency · same	71 Participants
Safety- Patient Symptoms Frequency · improved	122 Participants
Safety- Patient Symptoms Severity · worse	93 Participants
Safety- Patient Symptoms Severity · same	95 Participants
Safety- Patient Symptoms Severity · improved	121 Participants
Safety- Patient Symptoms Bothersome · worse	79 Participants
Safety- Patient Symptoms Bothersome · same	119 Participants
Safety- Patient Symptoms Bothersome · improved	111 Participants

Adverse Events

Treatment of Myopia

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment of Myopia n=336 participants at risk The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D. Treatment with the VisuMax™ Femtosecond Laser: The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D.
Eye disorders Decrease in BSCVA of greater than or equal to 2 lines	0.30% 1/336 • Number of events 1 • approximately 2 years, 11 months
Eye disorders Viral conjunctivitis	0.30% 1/336 • Number of events 1 • approximately 2 years, 11 months
Eye disorders Retinal vasculitis	0.30% 1/336 • Number of events 1 • approximately 2 years, 11 months
Eye disorders Conjunctival carcinoma in situ	0.30% 1/336 • Number of events 1 • approximately 2 years, 11 months
Eye disorders Allergic conjunctivitis	0.30% 1/336 • Number of events 1 • approximately 2 years, 11 months
Eye disorders Difficult lenticule removal with tissue damage	0.60% 2/336 • Number of events 2 • approximately 2 years, 11 months
Eye disorders Herpetic lid and corneal lesion	0.30% 1/336 • Number of events 1 • approximately 2 years, 11 months
Eye disorders Iritis	0.30% 1/336 • Number of events 1 • approximately 2 years, 11 months
Eye disorders Posterior vitreous detachment	0.30% 1/336 • Number of events 1 • approximately 2 years, 11 months
Eye disorders Perforated cap	0.30% 1/336 • Number of events 1 • approximately 2 years, 11 months
Eye disorders Pyogenic granuloma	0.30% 1/336 • Number of events 1 • approximately 2 years, 11 months
Eye disorders Retained tissue	0.60% 2/336 • Number of events 2 • approximately 2 years, 11 months

Additional Information

Todd Otani, Senior Clinical Research Scientist

Carl Zeiss Meditec, Inc.

Phone: 925-557-4513

Email: todd.otani@zeiss.com

Results disclosure agreements

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

Restriction type: LTE60