PhacoemulsificationNCT01247155
First Postoperative Day Review After Uneventful Phacoemulsification
An observational study of Phacoemulsification and Complications, run by Veroia General Hospital at 1 site in Greece.
Trial summary
The purpose of this randomized trial was to examine the value of the review on the first postoperative day after uneventful phacoemulsification cataract surgery. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Phacoemulsification, Complications, BCVA
- How many people
- Not given
- Where
- 1 siteGreece
- Study dates
- Start not givento not given
- 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 65 to 90 years
- All sexes
- Older adult
Study population: 291 consecutive patients who underwent uneventful phacoemulsification cataract surgery were randomized into two groups: i) Next day review (NDR group, n=146) and ii) No next day review (NNDR group, n=145).
Who may be able to join
None listed.
Who cannot join
- intra-operative complications, such as posterior capsule rupture, vitreous loss, lost nucleus, zonule dehiscence and wound leak,
- inadequate social support for overnight care at home,
- severely limited visual potential in the fellow eye,
- uveitis or ocular trauma,
- severe systemic diseases limiting activity,
- patients with learning disability or dementia.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this randomized trial was to examine the value of the review on the first postoperative day after uneventful phacoemulsification cataract surgery.
- Conditions
- Phacoemulsification, Complications, BCVA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| first day review | Not described | |
| non-first day review | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PhacoemulsificationStudies 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
- Case-control
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Veroia General Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01247155
- Sponsor's protocol ID
- 9151
- Status last verified
- Apr 2009
- First submitted
- 23 Nov 2010
- Last updated
- 24 Nov 2010
- Results posted
- No
Publications
Chatziralli IP, Sergentanis TN, Kanonidou E, Papazisis L. First postoperative day review after uneventful phacoemulsification cataract surgery: is it necessary? BMC Res Notes. 2012 Jun 27;5:333. doi: 10.1186/1756-0500-5-333.
PubMed 22738668
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Postoperative Day Review After Uneventful Phacoemulsification
- ClinicalTrials.gov ID
- NCT01247155
- Acronym / sponsor ID
- 9151
- Conditions
- Phacoemulsification, Complications, BCVA
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Veroia General HospitalUniversity, hospital or other
- First posted
- 24 Nov 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.
The purpose of this randomized trial was to examine the value of the review on the first postoperative day after uneventful phacoemulsification cataract surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| first day review | – | – |
| non-first day review | – | – |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Age groups
- Older adult
- Study population
- 291 consecutive patients who underwent uneventful phacoemulsification cataract surgery were randomized into two groups: i) Next day review (NDR group, n=146) and ii) No next day review (NNDR group, n=145).
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- intra-operative complications, such as posterior capsule rupture, vitreous loss, lost nucleus, zonule dehiscence and wound leak,
- inadequate social support for overnight care at home,
- severely limited visual potential in the fellow eye,
- uveitis or ocular trauma,
- severe systemic diseases limiting activity,
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
Best corrected visual acuity
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 24 Nov 2010.
- Derived from this study: PubMed 22738668Chatziralli IP, Sergentanis TN, Kanonidou E, Papazisis L. First postoperative day review after uneventful phacoemulsification cataract surgery: is it necessary? BMC Res Notes. 2012 Jun 27;5:333. doi: 10.1186/1756-0500-5-333.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Phacoemulsification and Complications, run by Veroia General Hospital at 1 site in Greece.
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 0 inclusion and 6 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 24 Nov 2010. 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 Greece. 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?
Best corrected visual acuity. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01247155, which also lists 1 linked publication.
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 24 Nov 2010.