CataractCHICANCT03685825
Impact of Ophthalmic Surgeon Experience on Early Postoperative Central Corneal Thickness
An observational study of Cataract, run by Centre Hospitalier Régional Metz-Thionville.
Trial summary
To assess the impact of surgeon experience on early postoperative central corneal thickness (CCT) in eyes that have undergone phacoemulsification-based cataract surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2013to 31 Mar 2014
- 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
- No healthy volunteers
- Adult, Older adult
Study population: One hundred sixty eyes underwent phacoemulsification-based cataract surgery performed by an experienced surgeon or a less surgically experienced ophtalmic assistant, using the divide-and-conquer or tilt-and-tumble technique for cataractous lens extraction.
Who may be able to join
- Presence of senile cataract
- Age above 50 years
- History of visual acuity regression
Who cannot join
- Presence of white or Brown cataract
- History of previous ophtalmic surgery
- preexisting corneal pathology (cornea guttata, infectious keratitis or active inflammatory or old)
- Patients who developed intraoperative complications
About this study
Official title: Impact of Ophthalmic Surgeon Experience on Early Postoperative Central Corneal Thickness After Cataract Surgery
To assess the impact of surgeon experience on early postoperative central corneal thickness (CCT) in eyes that have undergone phacoemulsification-based cataract surgery.
Read the detailed description
Cataract surgery is the most commonly performed surgical procedure. Although phacoemulsification is considered a safe method of performing cataract surgery, the risk of endothelial cell loss (ECL) remains.
Given that the surgical technique and speed typically improve with surgeon skill and experience, the purpose of this study was to evaluate the impact of surgeon experience on the occurrence of ECL, as reflected by the presence of corneal edema.
- Conditions
- Cataract
- Keywords
- Surgeon experience, Endothelial cell loss
- Medical subject headings
- Cataract
What is being measured
The primary outcome is the main question the study is designed to answer.
Early postoperative corneal edema
Calculated in micrometers, using pachymetric measurements to estimate central corneal thickness
Measured: hour 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start1 Oct 2013
- Primary completion1 Jan 2014
- Study completion31 Mar 2014
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
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03685825
- Sponsor's protocol ID
- 2015-14Obs-CHRMT
- Acronym
- CHICA
- Status last verified
- Aug 2018
- First submitted
- 25 Sep 2018
- Last updated
- 26 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Ophthalmic Surgeon Experience on Early Postoperative Central Corneal Thickness After Cataract Surgery
- ClinicalTrials.gov ID
- NCT03685825
- Acronym / sponsor ID
- CHICA / 2015-14Obs-CHRMT
- Conditions
- Cataract
- Keywords
- Surgeon experience, Endothelial cell loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 1 Jan 2014 (actual)
- Study completion
- 31 Mar 2014 (actual)
- First posted
- 26 Sep 2018 (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.
To assess the impact of surgeon experience on early postoperative central corneal thickness (CCT) in eyes that have undergone phacoemulsification-based cataract surgery.
Detailed description
Cataract surgery is the most commonly performed surgical procedure. Although phacoemulsification is considered a safe method of performing cataract surgery, the risk of endothelial cell loss (ECL) remains.
Given that the surgical technique and speed typically improve with surgeon skill and experience, the purpose of this study was to evaluate the impact of surgeon experience on the occurrence of ECL, as reflected by the presence of corneal edema.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- One hundred sixty eyes underwent phacoemulsification-based cataract surgery performed by an experienced surgeon or a less surgically experienced ophtalmic assistant, using the divide-and-conquer or tilt-and-tumble technique for cataractous lens extraction.
Key inclusion criteria (3 listed)
- Presence of senile cataract
- Age above 50 years
- History of visual acuity regression
Key exclusion criteria (4 listed)
- Presence of white or Brown cataract
- History of previous ophtalmic surgery
- preexisting corneal pathology (cornea guttata, infectious keratitis or active inflammatory or old)
- Patients who developed intraoperative complications
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
Early postoperative corneal edema
Time frame: hour 2
Calculated in micrometers, using pachymetric measurements to estimate central corneal thickness
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 Sep 2018.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by Centre Hospitalier Régional Metz-Thionville.
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 3 inclusion and 4 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 Sep 2018. 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.
What does the primary outcome measure?
Early postoperative corneal edema (time frame: hour 2). 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 26 Sep 2018.