CataractPhase 4NCT04230720
Effect of Artificial Tears on Biometry
A Phase 4 study testing Systane Complete in people with Cataract, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this study is to determine if measurements for cataract surgery are improved with use of additional lubrication with artificial tears. The research study is being done to optimize measurements and provide patients with the best visual outcomes after cataract surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Systane Complete
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2021to Dec 2021
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 18 years of age
- Documentation of bilateral age-related senile cataracts diagnosis
Who cannot join
- Patients currently using regularly scheduled artificial tears. Patients with infrequent or irregular use of artificial tears may not be excluded from the study.
- Patients using contact lenses.
- Patients with any other surface pathology affecting corneal biometric measurements determined with slit-lamp examination or medical history.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Ophthalmology
New York, New York, 10021
About this study
Official title: Impact of Lubrication With Artificial Tears on Biometry Measurements for Cataract Surgery
The purpose of this study is to determine if measurements for cataract surgery are improved with use of additional lubrication with artificial tears. The research study is being done to optimize measurements and provide patients with the best visual outcomes after cataract surgery.
- Conditions
- Cataract
- Being tested
- Systane Complete
- Keywords
- biometry measurement, artificial tear, cataract surgery
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systane CompleteDrug
1 drop 4 times a day for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Artificial Tears | Experimental | One eye of each participant is randomized to receive Systane Complete artificial tears 4 times a day for 14 days Receives: Drug: Systane Complete |
| No Artificial Tears | No intervention | One eye of each participant is randomized to receive no artificial tears for 14 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Baseline in Keratometry Values (K1 and K2)
The change in keratometry (K) values (K1 and K2) in all subjects
Measured: Baseline, Day 14
Change in Baseline in Axis of Astigmatism
The change in axis of astigmatism in all subjects
Measured: Baseline, Day 14
Secondary outcomes (3)
Change in Baseline Calculated Intraocular Lens Power
The change in intraocular lens power calculation in all subjects
Measured: Baseline, Day 14
Change in Keratometry Values (K1 and K2) in Ocular Surface Disease Subjects
The change in keratometry (K) values (K1 and K2) in a subset of subjects that were positive for ocular surface disease on the American Society of Cataract and Refractive Surgery (ASCRS) modified Standardized Patient Evaluation of Eye Dryness (SPEED2) questionnaire
Measured: Baseline, Day 14
Change in Axis of Astigmatism in Ocular Surface Disease Subjects
The change in axis of corneal astigmatism in a subset of subjects that were positive for ocular surface disease on the American Society of Cataract and Refractive Surgery (ASCRS) modified Standardized Patient Evaluation of Eye Dryness (SPEED2) questionnaire
Measured: Baseline, Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study startApr 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: Stopped due to COVID-19.
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashley Brissette, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04230720
- Sponsor's protocol ID
- 19-11021101
- Status last verified
- Jun 2021
- First submitted
- 14 Jan 2020
- Last updated
- 22 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Lubrication With Artificial Tears on Biometry Measurements for Cataract Surgery
- ClinicalTrials.gov ID
- NCT04230720
- Acronym / sponsor ID
- 19-11021101
- Conditions
- Cataract
- Keywords
- biometry measurement, artificial tear, cataract surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Stopped due to COVID-19.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Apr 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 18 Jan 2020 (actual)
- 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.
The purpose of this study is to determine if measurements for cataract surgery are improved with use of additional lubrication with artificial tears. The research study is being done to optimize measurements and provide patients with the best visual outcomes after cataract surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Artificial Tears | Experimental | Drug: Systane CompleteOne eye of each participant is randomized to receive Systane Complete artificial tears 4 times a day for 14 days |
| No Artificial Tears | No intervention | –One eye of each participant is randomized to receive no artificial tears for 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female ≥ 18 years of age
- Documentation of bilateral age-related senile cataracts diagnosis
Key exclusion criteria (3 listed)
- Patients currently using regularly scheduled artificial tears. Patients with infrequent or irregular use of artificial tears may not be excluded from the study.
- Patients using contact lenses.
- Patients with any other surface pathology affecting corneal biometric measurements determined with slit-lamp examination or medical history.
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 |
|---|---|---|
| Systane Complete1 drop 4 times a day for 14 days | Drug | Artificial Tears |
Primary outcome
Change in Baseline in Keratometry Values (K1 and K2)
Time frame: Baseline, Day 14
The change in keratometry (K) values (K1 and K2) in all subjects
Change in Baseline in Axis of Astigmatism
Time frame: Baseline, Day 14
The change in axis of astigmatism in all subjects
3 secondary outcomes
Change in Baseline Calculated Intraocular Lens Power
Time frame: Baseline, Day 14
Change in Keratometry Values (K1 and K2) in Ocular Surface Disease Subjects
Time frame: Baseline, Day 14
Change in Axis of Astigmatism in Ocular Surface Disease Subjects
Time frame: Baseline, Day 14
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
- Individual participant dataSharing planned: No
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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.
Ashley Brissette, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Systane Complete in people with Cataract, run by Weill Medical College of Cornell University at 1 site 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 3 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: withdrawn, as of the sponsor's last update on 22 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in Baseline in Keratometry Values (K1 and K2) (time frame: Baseline, Day 14). 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 22 Jun 2021; AzTrials last refreshed its copy on 30 Oct 2026.