CataractNCT04747834
Assessment of Low Energy Lens Fragmentation Cataract Extraction in Patients Undergoing Cataract Surgery
A study testing MICOR-304 in people with Cataract, run by Carl Zeiss Meditec, Inc. at 3 sites in United States.
Trial summary
The purpose of this research study is to evaluate the clinical outcomes of the use of low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion in subjects undergoing routine cataract surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- MICOR-304
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- 6 Jan 2021to 24 Jan 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to understand study requirements, willing to follow study instructions and willing to return for required study follow-up visits
- Willing and able to understand and complete the informed consent document
- Subjects with a cataract grade of 1 to 3+ and are scheduled to undergo cataract surgery
- Subjects ≥ 18 years of age
- Clear intraocular media, other than cataract
Who cannot join
- Polar cataracts
- Zonular instability
- History of dry eye treatments/devices and or dry eye medications other than artificial tears.
- Concurrent participation or participation in any clinical trial up to 30 days prior to preoperative visit
- Subjects that are pregnant, lactating or planning to become pregnant during the course of the study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Chu Vision Institute
Bloomington, Minnesota, 55420
Argus Research at Cape Coral Eye Center
Cape Coral, Florida, 33904
Young H. Choi Eye Surgery Center
Vestavia Hills, Alabama, 35243
About this study
Official title: A Prospective Multicenter Study to Assess The Clinical Outcomes of Low Energy Lens Fragmentation Cataract Extraction in Patients Undergoing Cataract Surgery
The purpose of this research study is to evaluate the clinical outcomes of the use of low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion in subjects undergoing routine cataract surgery.
Read the detailed description
Up to 300 eyes at up to 5 investigational sites will be enrolled in one of the two cohorts of this clinical investigation - up to 50 eyes in Cohort 1 and up to 50 eyes in Cohort 2. Only one eye per subject will be enrolled into the study. This is multicenter, multi-cohort, prospective clinical study designed to provide longitudinal, observational, non-comparative clinical outcome data for mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.
Participants who meet the inclusion and exclusion will be asked to enroll in the study. The investigator or designee will explain the study purpose, procedures and responsibilities to the potential participant and provide sufficient opportunity to ask questions, while allowing adequate time for consideration of the information provided. Upon participant confirmation of interest, written informed consent will be obtained and the subject will be enrolled in the study. One copy of the informed consent document (ICD) will be retained with the subject's medical records and one copy will be provided to the subject.
Study subjects will be stratified into two Cohorts. Cohort 1 is comprised of eyes with mild-to- moderate cataracts only (Grade 1 to 2). Cohort 2 is comprised of eyes with moderate to more dense cataracts only (Grade 2+ to 3+).
Subjects will be seen at the screening visit, intraoperative visit, and at post-operative days 1, 7, and 30.
- Conditions
- Cataract
- Being tested
- MICOR-304
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MICOR-304Device
The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Active comparator | Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. Receives: Device: MICOR-304 |
| Cohort 2 | Active comparator | Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. Receives: Device: MICOR-304 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Lens Removal Time
Total lens removal time is defined in two phases:
- The beginning time starts when the surgeon enters the eye with the MICOR-304 to start the lens removal process and completing when the surgeon finishes the nucleus lens removal with the MICOR-304 before changing over to irrigation and aspiration.
- The second phase of lens removal time is the irrigation and aspiration stage for cortex removal which starts when the irrigation and aspiration tip enters the eye and completion time is when the cortex is removed.
The total lens removal time as defined above is recorded in minutes and seconds.
Measured: Assessed during the surgical procedure, measured in seconds.
Amount of Irrigation Solution Fluid Volume Used During the Surgical Procedure
Total irrigation solution volume will be recorded using the indicators on the bag which will have labels that have pre-defined markers to indicate milliliters (ml) of volume of irrigation solution used for the surgical procedure.
Measured: Assessed during the surgical procedure, approximately 8 - 10 minutes.
Secondary outcomes (37)
Total Surgical Procedure Time
Total Surgical Procedure Time time is defined as the beginning time when the surgeon makes the first incision in the eye and completion time is when the eye speculum is removed at the end of the procedure. Total surgical procedure time is recorded in minutes and seconds.
Measured: Assessed during the surgical procedure.
UCVA at 1-Day
Assessment of subjects uncorrected visual acuity (UCVA) at day 1 postoperative. Visual acuity is assessed by the healthcare provider without the aid of glasses or spectacles.
Measured: Postoperative 1 Day
BCDVA at 1 Week
Assessment of best-corrected distance visual acuity (BCDVA) at the 1-week postoperative visit. BCDVA is assessed by the healthcare provider and is a measurement of how well someone can see at 6m with corrective lenses, such as glasses or contact lenses.
Measured: 1- week postoperative
BCDVA at 1 Month
Assessment of BCDVA at the 1 Month postoperative visit
Measured: 1 month postoperative
Change in Corneal Thickness
Assessment in the mean change in corneal thickness from baseline exam through the end of the study. Corneal thickness is measured using pachymetry presented with unit of measure "μm".
Measured: Measured at Baseline, 1 Day, 1 Week and 1 Month postoperative.
Corneal Edema
Corneal edema will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3+=Severe
Measured: Pre-operative
Corneal Edema 1 Day Postoperative
Corneal edema will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate, 3+=Severe
Measured: 1 Day Postoperative
Corneal Edema 1-Week Postoperative
Corneal edema will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate, 3+=Severe
Measured: 1-Week Postoperative
Corneal Edema 1 Month Postoperative
Corneal edema will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3+=Severe
Measured: 1 Month Postoperative
Corneal Cells
Corneal cells will be assessed as the following: 0=>1 cell, 0.5+=1-5 cells, 1+=6-15 cells, 2+=16-25 cells, 3+=26-50 cells and 4+=>50 cells.
Measured: Pre-operative
Corneal Cells
Corneal cells will be assessed as the following: 0=>1 cell, 0.5+=1-5 cells, 1+=6-15 cells, 2+=16-25 cells, 3+=26-50 cells and 4+=>50 cells
Measured: 1 Day Postoperative
Corneal Cells
Corneal cells will be assessed as the following: 0=>1 cell, 0.5+=1-5 cells, 1+=6-15 cells, 2+=16-25 cells, 3+=26-50 cells and 4+=>50 cells
Measured: 1-Week Postoperative
Corneal Cells
Corneal cells will be assessed as the following: 0=>1 cell, 0.5+=1-5 cells, 1+=6-15 cells, 2+=16-25 cells, 3+=26-50 cells and 4+=>50 cells
Measured: 1-Month Postoperative
Anterior Chamber Flare
Anterior chamber flare will be assessed as the following: 0-None, 1+=Faint, 2+=Moderate, (iris and lens details clear), 3+=Marked (iris and lens details hazy), 4+=Intense fibrin or plastic aqueous.
Measured: Pre-operative
Anterior Chamber Flare
Anterior chamber flare will be assessed as the following: 0-None, 1+=Faint, 2+=Moderate, (iris and lens details clear), 3+=Marked (iris and lens details hazy), 4+=Intense fibrin or plastic aqueous.
Measured: 1-Day Postoperative
Anterior Chamber Flare
Anterior chamber flare will be assessed as the following: 0-None, 1+=Faint, 2+=Moderate, (iris and lens details clear), 3+=Marked (iris and lens details hazy), 4+=Intense fibrin or plastic aqueous.
Measured: 1-Week Postoperative
Anterior Chamber Flare
Anterior chamber flare will be assessed as the following: 0-None, 1+=Faint, 2+=Moderate, (iris and lens details clear), 3+=Marked (iris and lens details hazy), 4+=Intense fibrin or plastic aqueous.
Measured: 1-Month Postoperative
Posterior Capsule Opacification
Posterior capsule opacification will be assessed as the following: none, minimal, mild, moderate and severe.
Measured: Pre-operative
Posterior Capsule Opacification
Posterior capsule opacification will be assessed as the following: none, minimal, mild, moderate and severe.
Measured: 1-Day Postoperative
Posterior Capsule Opacificaiton
Posterior capsule opacification will be assessed as the following: none, minimal, mild, moderate and severe.
Measured: 1-Week Postoperative
Posterior Capsule Opacification
Posterior capsule opacification will be assessed as the following: none, minimal, mild, moderate and severe.
Measured: 1-Month Postoperative
Corneal Staining Erosion
Corneal staining erosion will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3=Severe
Measured: Pre-operative
Corneal Staining Erosion
Corneal staining erosion will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3=Severe
Measured: 1-Day Postoperative
Corneal Staining Erosion
Corneal staining erosion will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3=Severe
Measured: 1-Week Postoperative
Corneal Staining Erosion
Corneal staining erosion will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3=Severe
Measured: 1-Month Postoperative
Other Slit-Lamp Findings
Assessment of other slit-lamp exam findings not listed on data collection form.
Measured: Preoperative
Other Slit-Lamp Findings
Assessment of other slit-lamp exam findings not listed on data collection form.
Measured: 1-Day Postoperative
Other Slit-Lamp Findings
Assessment of other slit-lamp exam findings not listed on data collection form.
Measured: 1-Week Postoperative
Other Slit-Lamp Findings
Assessment of other slit-lamp exam findings not listed on data collection form.
Measured: 1-Month Postoperative
Macula
Macula is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.
Measured: Pre-operative
Macula
Macula is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.
Measured: 1-Month Postoperative
Disc Appearance
Disc appearance is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.
Measured: Pre-operative
Disc Appearance
Disc appearance is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.
Measured: 1-Month Postoperative
Vessels
Vessels are assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.
Measured: Pre-operative
Vessels
Vessels are assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.
Measured: 1-Month Postoperative
Periphery
Periphery is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.
Measured: Pre-operative
Periphery
Periphery is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.
Measured: 1-Month Postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start6 Jan 2021
- Primary completion24 Jan 2022
- Study completion24 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be stratified into two Cohorts. Cohort 1 is comprised of eyes with mild-to- moderate cataracts only (Grade 1 to 2). Cohort 2 is comprised of eyes with moderate to more dense cataracts only (Grade 2+ to 3+).
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carl Zeiss Meditec, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Farrell C. Tyson, M.D., Principal investigator, Argus Research at Cape Coral Eye CenterYoung H. Choi, M.D., Principal investigator, Young H Choi Eye Surgery Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04747834
- Sponsor's protocol ID
- MICOR-304-101
- Status last verified
- Jun 2024
- First submitted
- 2 Feb 2021
- Last updated
- 6 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Study to Assess The Clinical Outcomes of Low Energy Lens Fragmentation Cataract Extraction in Patients Undergoing Cataract Surgery
- ClinicalTrials.gov ID
- NCT04747834
- Acronym / sponsor ID
- MICOR-304-101
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Carl Zeiss Meditec, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 24 Jan 2022 (actual)
- Study completion
- 24 Jan 2022 (actual)
- First posted
- 10 Feb 2021 (actual)
- Results
- Posted 6 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to evaluate the clinical outcomes of the use of low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion in subjects undergoing routine cataract surgery.
Detailed description
Up to 300 eyes at up to 5 investigational sites will be enrolled in one of the two cohorts of this clinical investigation - up to 50 eyes in Cohort 1 and up to 50 eyes in Cohort 2. Only one eye per subject will be enrolled into the study. This is multicenter, multi-cohort, prospective clinical study designed to provide longitudinal, observational, non-comparative clinical outcome data for mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.
Participants who meet the inclusion and exclusion will be asked to enroll in the study. The investigator or designee will explain the study purpose, procedures and responsibilities to the potential participant and provide sufficient opportunity to ask questions, while allowing adequate time for consideration of the information provided. Upon participant confirmation of interest, written informed consent will be obtained and the subject will be enrolled in the study. One copy of the informed consent document (ICD) will be retained with the subject's medical records and one copy will be provided to the subject.
Study subjects will be stratified into two Cohorts. Cohort 1 is comprised of eyes with mild-to- moderate cataracts only (Grade 1 to 2). Cohort 2 is comprised of eyes with moderate to more dense cataracts only (Grade 2+ to 3+).
Subjects will be seen at the screening visit, intraoperative visit, and at post-operative days 1, 7, and 30.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be stratified into two Cohorts. Cohort 1 is comprised of eyes with mild-to- moderate cataracts only (Grade 1 to 2). Cohort 2 is comprised of eyes with moderate to more dense cataracts only (Grade 2+ to 3+).
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Active comparator | Device: MICOR-304Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. |
| Cohort 2 | Active comparator | Device: MICOR-304Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to understand study requirements, willing to follow study instructions and willing to return for required study follow-up visits
- Willing and able to understand and complete the informed consent document
- Subjects with a cataract grade of 1 to 3+ and are scheduled to undergo cataract surgery
- Subjects ≥ 18 years of age
- Clear intraocular media, other than cataract
Key exclusion criteria (5 listed)
- Polar cataracts
- Zonular instability
- History of dry eye treatments/devices and or dry eye medications other than artificial tears.
- Concurrent participation or participation in any clinical trial up to 30 days prior to preoperative visit
- Subjects that are pregnant, lactating or planning to become pregnant during the course of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MICOR-304The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision. | Device | Cohort 1, Cohort 2 |
Primary outcome
Total Lens Removal Time
Time frame: Assessed during the surgical procedure, measured in seconds.
Total lens removal time is defined in two phases: * The beginning time starts when the surgeon enters the eye with the MICOR-304 to start the lens removal process and completing when the surgeon finishes the nucleus lens removal with the MICOR-304 before changing over to irrigation and aspiration. * The second phase of lens removal time is the irrigation and aspiration stage for cortex removal which starts when the irrigation and aspiration tip enters the eye and completion time is when the cortex is removed. The total lens removal time as defined above is recorded in minutes and seconds.
Amount of Irrigation Solution Fluid Volume Used During the Surgical Procedure
Time frame: Assessed during the surgical procedure, approximately 8 - 10 minutes.
Total irrigation solution volume will be recorded using the indicators on the bag which will have labels that have pre-defined markers to indicate milliliters (ml) of volume of irrigation solution used for the surgical procedure.
37 secondary outcomes
Total Surgical Procedure Time
Time frame: Assessed during the surgical procedure.
UCVA at 1-Day
Time frame: Postoperative 1 Day
BCDVA at 1 Week
Time frame: 1- week postoperative
BCDVA at 1 Month
Time frame: 1 month postoperative
Change in Corneal Thickness
Time frame: Measured at Baseline, 1 Day, 1 Week and 1 Month postoperative.
Corneal Edema
Time frame: Pre-operative
Corneal Edema 1 Day Postoperative
Time frame: 1 Day Postoperative
Corneal Edema 1-Week Postoperative
Time frame: 1-Week Postoperative
Corneal Edema 1 Month Postoperative
Time frame: 1 Month Postoperative
Corneal Cells
Time frame: Pre-operative
Corneal Cells
Time frame: 1 Day Postoperative
Corneal Cells
Time frame: 1-Week Postoperative
Corneal Cells
Time frame: 1-Month Postoperative
Anterior Chamber Flare
Time frame: Pre-operative
Anterior Chamber Flare
Time frame: 1-Day Postoperative
Anterior Chamber Flare
Time frame: 1-Week Postoperative
Anterior Chamber Flare
Time frame: 1-Month Postoperative
Posterior Capsule Opacification
Time frame: Pre-operative
Posterior Capsule Opacification
Time frame: 1-Day Postoperative
Posterior Capsule Opacificaiton
Time frame: 1-Week Postoperative
Posterior Capsule Opacification
Time frame: 1-Month Postoperative
Corneal Staining Erosion
Time frame: Pre-operative
Corneal Staining Erosion
Time frame: 1-Day Postoperative
Corneal Staining Erosion
Time frame: 1-Week Postoperative
Corneal Staining Erosion
Time frame: 1-Month Postoperative
Other Slit-Lamp Findings
Time frame: Preoperative
Other Slit-Lamp Findings
Time frame: 1-Day Postoperative
Other Slit-Lamp Findings
Time frame: 1-Week Postoperative
Other Slit-Lamp Findings
Time frame: 1-Month Postoperative
Macula
Time frame: Pre-operative
Macula
Time frame: 1-Month Postoperative
Disc Appearance
Time frame: Pre-operative
Disc Appearance
Time frame: 1-Month Postoperative
Vessels
Time frame: Pre-operative
Vessels
Time frame: 1-Month Postoperative
Periphery
Time frame: Pre-operative
Periphery
Time frame: 1-Month Postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farrell C. Tyson, M.D. principal investigator
Argus Research at Cape Coral Eye Center
Young H. Choi, M.D. principal investigator
Young H Choi Eye Surgery Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MICOR-304 in people with Cataract, run by Carl Zeiss Meditec, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Lens Removal Time (time frame: Assessed during the surgical procedure, measured in seconds.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.