Postmarket Study of outcomes from WaveLight® EX500 InnovEyes™ treatment in conjunction with the InnovEyes™ Sightmap
Organizational Data
- DRKS-ID:
- DRKS00020388
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2020-03-12
- Last update in DRKS:
- 2022-09-05
- Registration type:
- Prospective
Acronym/abbreviation of the study
RFP911-P001
URL of the study
No Entry
Brief summary in lay language
The purpose of this research study is to obtain information on the safety and effectiveness of the WaveLight EX500 laser using InnovEyes along with eye measurements from the InnovEyes sightmap.
Brief summary in scientific language
The purpose of this clinical study is to determine the safety and effectiveness of the WaveLight EX500 excimer laser system for the correction of myopia with and without astigmatism using InnovEyes in conjunction with the InnovEyes sightmap.
Health condition or problem studied
- ICD10:
- H52.2 - Astigmatism
- ICD10:
- H52.1 - Myopia
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- WaveLight EX500 using InnovEyes in conjunction with InnovEyes Sightmap
Endpoints
- Primary outcome:
- Percentage of eyes with absolute MRSE within ±0.25, ±0.50, ±0.75 and ±1.00 D at 3 months postoperative
- Secondary outcome:
- No Entry
Study Design
- Purpose:
- Treatment
- Allocation:
- N/A (single arm study)
- Control:
-
- Uncontrolled/single arm
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Single (group)
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Australia
- Germany
- Greece
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- Doctor's practice Köln
Recruitment period and number of participants
- Planned study start date:
- 2020-03-20
- Actual study start date:
- 2020-07-07
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2021-09-30
- Target Sample Size:
- 120
- Final Sample Size:
- 136
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 21 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- - Minimum of 21 years of age - Myopia up to and including -11.00 D with or without astigmatism up to -4.50 D - BCDVA of 20/20 or better Other protocol-defined inclusion criteria may apply
Exclusion Criteria
- Acute or chronic disease or illness that would increase the operative risk or confound the outcomes of the study. - Previous intraocular or corneal surgery - Participation in other clinical trials during the course of the study that may confound study results Other protocol-defined exclusion criteria may apply.
Addresses
Primary Sponsor
- Address:
- Alcon Research, LLC6201 South Freeway76134-2099 Fort Worth, TexasUnited States
- Telephone:
- 1-888451-3937
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.alcon.com
- Investigator Sponsored/Initiated Trial (IST/IIT):
- No
Contact for Scientific Queries
- Address:
- Alcon Research, LLCMaria Jockovich6201 South Freeway76134-2099 Fort Worth, TexasUnited States
- Telephone:
- 1-888-451-3937
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.alcon.com
Contact for Public Queries
- Address:
- Alcon Research, LLCMaria Jockovich6201 South Freeway76134-2099 Fort Worth, TexasUnited States
- Telephone:
- 1-888-451-3937
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.alcon.com
Principal Investigator
- Address:
- Alcon Research, LLCMaria Jockovich6201 South Freeway76134-2099 Fort Worth, TexasUnited States
- Telephone:
- 1-888-451-3937
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.alcon.com
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- Alcon Research, LLC and its affiliates (“Alcon”)6201 South Freeway76134-2099 Fort Worth, TexasUnited States
- Telephone:
- 1-888-451-3937
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.alcon.com
Ethics Committee
Address Ethics Committee
- Address:
- Bellberry Human Research Ethics Committee [Bellberry HREC Australia]123 Glen Osmand Road5063 EastwoodAustralia
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.bellberry.com.au
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2019-12-20
- Ethics committee number:
- 2019-12-1167
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2020-03-10
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry