CataractNCT01471561
Analysis of Cataract Surgery Induced Dry Eye
An observational study of Cataract, run by TearLab Corporation at 4 sites in United States.
Trial summary
This is a retrospective study to determine if rates of osmolarity and dry eye disease symptoms increase following 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
- How many people
- 61 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2011to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: 1. Male or female, eighteen years of age or older 2. Confirmed diagnosis of cataract with cataract surgery performed in at least one eye
Who may be able to join
- Male or female, eighteen years of age or older
- Confirmed diagnosis of cataract with cataract surgery performed in at least one eye
Who cannot join
- 1. Any complications of cataract surgery that have required a sclera incision rather than a clear corneal incision.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
William Trattler, MD
Miami, Florida, 33176
David Hardten, MD
Minneapolis, Minnesota, 55404
Chris Starr, MD
New York, New York, 10021
Eric Donnenfeld, MD
Rockville Centre, New York, 11570
About this study
Official title: Retrospective Analysis of Cataract Surgery-induced Dry Eye Using Tear Osmolarity Testing
This is a retrospective study to determine if rates of osmolarity and dry eye disease symptoms increase following cataract surgery.
Read the detailed description
The objective of this study is to determine if tear osmolarity is a good predictor for dry eye following cataract surgery.
The practice will retrospectively identify patients that have had cataract surgery from billing records. This will be cross referenced with patients that have had the diagnosis of dry eye and have had tear osmolarity testing, also from billing or electronic records analysis. The studies will be done at sites that have inclusion of a general statement about record review for research in the patient intake information at the practice. Information will be taken from the baseline visit at the final pre-operative examination prior to cataract surgery from these patients who have had tear osmolarity measured on each eye using the TearLab osmolarity device.
Because this is a retrospective study, patients will have followed each surgeon's typical pre-operative and post-operative protocol (i.e., lid cleansing, topical antibiotics, steroids, NSAIDS, etc.) without other peri-surgical complications, and followed at the normal post-operative follow-up appointments. Whenever tear osmolarity measurements had been taken and recorded in the patient's chart, this information will be collected from the patient's chart and recorded in a database. Information from visits up to and including the 3 month postoperative interval will be recorded. Additional information recorded will be demographic information such as age, corrected vision before and after the cataract surgery at the one month visit as well as at any time that tear osmolarity is measured. Additionally, any comments made in the history of present illness statement regarding dryness will be recorded in the database. Presence of other ocular surface disease present such as blepharitis, allergic disease, or anterior basement membrane dystrophy will be recorded. Systemic medications that the patient is taking will also be recorded. Presence or absence of diabetes mellitus will also be recorded. The database will be kept in a password protected computer in a locked office location, and every precaution will be taken to prevent identification of any patient specific identifiers. Information will be de-identified as soon as possible by using codes to identify the data rather than patient names or chart numbers.
- Conditions
- Cataract
- Keywords
- Osmolarity, Cataract, Dry Eye
- Medical subject headings
- Cataract, Dry Eye Syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
Post surgical tear osmolarity
Correlation between pre-surgery value and development of dry eye disease post surgery
- Comparison of Osmolarity measurement pre to post-op, as well as over time, to determine change and statistical significance
Measured: 90-Day post-surgical
Secondary outcomes (1)
Post-surgical dry eye symptoms
Correlation between pre-surgery value and development of dry eye disease post surgery.
- Subjective patient reporting on dry eye symptoms from pre to postoperative
Measured: 90-Day post-surgical
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- TearLab Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gaston Lacayo, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01471561
- Sponsor's protocol ID
- TP00099
- Status last verified
- Feb 2016
- First submitted
- 10 Nov 2011
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Cataract Surgery-induced Dry Eye Using Tear Osmolarity Testing
- ClinicalTrials.gov ID
- NCT01471561
- Acronym / sponsor ID
- TP00099
- Conditions
- Cataract
- Keywords
- Osmolarity, Cataract, Dry Eye
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- TearLab CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 16 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a retrospective study to determine if rates of osmolarity and dry eye disease symptoms increase following cataract surgery.
Detailed description
The objective of this study is to determine if tear osmolarity is a good predictor for dry eye following cataract surgery.
The practice will retrospectively identify patients that have had cataract surgery from billing records. This will be cross referenced with patients that have had the diagnosis of dry eye and have had tear osmolarity testing, also from billing or electronic records analysis. The studies will be done at sites that have inclusion of a general statement about record review for research in the patient intake information at the practice. Information will be taken from the baseline visit at the final pre-operative examination prior to cataract surgery from these patients who have had tear osmolarity measured on each eye using the TearLab osmolarity device.
Because this is a retrospective study, patients will have followed each surgeon's typical pre-operative and post-operative protocol (i.e., lid cleansing, topical antibiotics, steroids, NSAIDS, etc.) without other peri-surgical complications, and followed at the normal post-operative follow-up appointments. Whenever tear osmolarity measurements had been taken and recorded in the patient's chart, this information will be collected from the patient's chart and recorded in a database. Information from visits up to and including the 3 month postoperative interval will be recorded. Additional information recorded will be demographic information such as age, corrected vision before and after the cataract surgery at the one month visit as well as at any time that tear osmolarity is measured. Additionally, any comments made in the history of present illness statement regarding dryness will be recorded in the database. Presence of other ocular surface disease present such as blepharitis, allergic disease, or anterior basement membrane dystrophy will be recorded. Systemic medications that the patient is taking will also be recorded. Presence or absence of diabetes mellitus will also be recorded. The database will be kept in a password protected computer in a locked office location, and every precaution will be taken to prevent identification of any patient specific identifiers. Information will be de-identified as soon as possible by using codes to identify the data rather than patient names or chart numbers.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Male or female, eighteen years of age or older 2. Confirmed diagnosis of cataract with cataract surgery performed in at least one eye
Key inclusion criteria (2 listed)
- Male or female, eighteen years of age or older
- Confirmed diagnosis of cataract with cataract surgery performed in at least one eye
Key exclusion criteria (1 listed)
- 1. Any complications of cataract surgery that have required a sclera incision rather than a clear corneal incision.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Post surgical tear osmolarity
Time frame: 90-Day post-surgical
Correlation between pre-surgery value and development of dry eye disease post surgery 1) Comparison of Osmolarity measurement pre to post-op, as well as over time, to determine change and statistical significance
1 secondary outcome
Post-surgical dry eye symptoms
Time frame: 90-Day post-surgical
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.
- Individual participant dataSharing planned: No. No data will be shared.
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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.
Gaston Lacayo, MD principal investigator
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by TearLab Corporation at 4 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 2 inclusion and 1 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 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Post surgical tear osmolarity (time frame: 90-Day post-surgical). 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 4 Feb 2016.