Pupil Dilation Prior to Cataract Surgery In-patientNCT01169688
Preoperative Cataract Pupillary Dilation: Inpatient At The Ambulatory Surgery Center vs Outpatient Dilation Prior To Arrival At The Ambulatory Surgery Center
A study testing Pupil dilation with phenylephrine 10% vs cyclopentolate 2% in people with Pupil Dilation Prior to Cataract Surgery In-patient and Pupil Dilation Prior to Cataract Surgery Out-patient, run by Northwest Kansas Surgery Center.
Trial summary
This study was done to compare efficacy, safety and efficiencies of various methods of pupil dilation prior to cataract surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pupil Dilation Prior to Cataract Surgery In-patient, Pupil Dilation Prior to Cataract Surgery Out-patient
- What is being tested?
- Pupil dilation with phenylephrine 10% vs cyclopentolate 2%
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Dec 2007to Apr 2008
- Phase
- Interventional
- 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
- Ability to self administer eye or have a helper for the task of administering eye drops.
- Ability to follow and eye drop administration schedule.
- No noted ocular abnormalities.
- Bilateral cataract surgery anticipated.
Who cannot join
- Inability to self administer eye drops or have assistance with eye drop administration.
- Health problems that would contraindicate self administration of dilating eye drops such as poor cardiovascular or respiratory status.
About this study
Official title: Preoperative Cataract Pupillary Dilation: Inpatient vs Outpatient
This study was done to compare efficacy, safety and efficiencies of various methods of pupil dilation prior to cataract surgery.
- Conditions
- Pupil Dilation Prior to Cataract Surgery In-patient, Pupil Dilation Prior to Cataract Surgery Out-patient
- Being tested
- Pupil dilation with phenylephrine 10% vs cyclopentolate 2%
- Keywords
- Cataract Surgery, Pupillary Dilation
- Medical subject headings
- Mydriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pupil dilation with phenylephrine 10% vs cyclopentolate 2%Other
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2010 (estimated)
- Study startDec 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pupil Dilation Prior to Cataract Surgery In-patientStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwest Kansas Surgery Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01169688
- Sponsor's protocol ID
- NWKSC_2007_01
- Status last verified
- Dec 2007
- First submitted
- 22 Jul 2010
- Last updated
- 26 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Cataract Pupillary Dilation: Inpatient vs Outpatient
- ClinicalTrials.gov ID
- NCT01169688
- Acronym / sponsor ID
- NWKSC_2007_01
- Conditions
- Pupil Dilation Prior to Cataract Surgery In-patient, Pupil Dilation Prior to Cataract Surgery Out-patient
- Keywords
- Cataract Surgery, Pupillary Dilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Northwest Kansas Surgery CenterUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 26 Jul 2010 (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 study was done to compare efficacy, safety and efficiencies of various methods of pupil dilation prior to cataract surgery.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ability to self administer eye or have a helper for the task of administering eye drops.
- Ability to follow and eye drop administration schedule.
- No noted ocular abnormalities.
- Bilateral cataract surgery anticipated.
Key exclusion criteria (2 listed)
- Inability to self administer eye drops or have assistance with eye drop administration.
- Health problems that would contraindicate self administration of dilating eye drops such as poor cardiovascular or respiratory status.
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 |
|---|---|---|
| Pupil dilation with phenylephrine 10% vs cyclopentolate 2% | Other | – |
Primary outcome
Not reported in the source record.
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 26 Jul 2010.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Pupil dilation with phenylephrine 10% vs cyclopentolate 2% in people with Pupil Dilation Prior to Cataract Surgery In-patient and Pupil Dilation Prior to Cataract Surgery Out-patient, run by Northwest Kansas Surgery Center.
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 4 inclusion and 2 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 26 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
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.
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 26 Jul 2010.