CataractCOPHANCT03689270
Corneal Edema After Phacoemulsification
An observational study of Cataract, run by Centre Hospitalier Régional Metz-Thionville.
Trial summary
To compare the impact of two phacoemulsification techniques (subluxation versus divide-and-conquer) on postoperative corneal edema at postoperative hour 1 and day 4. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Subluxation and Divide and conquer
- Type of treatment
- Surgery or procedure
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Dec 2015
- 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: Patients underwent phacoemulsification cataract surgery over a 6-month period.
Who may be able to join
- The presence of a senile cataract with equivalent grades and history of visual acuity regression
- Informed written consent
Who cannot join
- Patients with total white cataract
- With history of ocular surgery and other eye diseases (corneal pathology, uveitis, glaucoma)
- With systemic diseases with the potential to affect vision
About this study
Official title: Central Corneal Thickness Assessment After Phacoemulsification: Subluxation Versus Divide-and-Conquer
To compare the impact of two phacoemulsification techniques (subluxation versus divide-and-conquer) on postoperative corneal edema at postoperative hour 1 and day 4.
Read the detailed description
Phacoemulsification is the procedure of choice for most surgeons performing cataract surgery. Alternative techniques have been in development over the last twenty years, with the hope of optimizing operating times, total ultrasound energy used, patient safety, patient satisfaction and visual recovery associated with cataract surgery.
Divide-and conquer is the parent nucleofracture technique.The subluxation technique is a newer technique that is less frequently used because of an increased risk of corneal endothelium damage.
The aim of this comparative study was to evaluate corneal edema immediately after surgery performed with the subluxation technique versus divide-and-conquer. Corneal edema was determined by measuring central corneal thickness (CCT).
- Conditions
- Cataract
- Being tested
- Subluxation, Divide and conquer
- Keywords
- subluxation, Divide and conquer
- Medical subject headings
- Cataract, Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SubluxationProcedure or surgery
One pole of The nucleus is hydrodissected until it lilts above the capsular bag. The tilted nucleus is rotated to face the incision and remaining half nucleus is then tumbled and emulsification continues from the opposite equator outside in until complete.
Divide and conquerProcedure or surgery
Cataract nucleus is fragmented into 4 pieces then aspirated by ultrasonic vibration
| Study group | Role | What they receive |
|---|---|---|
| Subluxation | Nucleus is hydrodissected until it lilts above the capsular bag, rotated to face the incision then tumbled and emulsification continues from the opposite equator outside in until complete Receives: Procedure: Subluxation | |
| Divide and Conquer | Cataract nucleus is fragmented into 4 pieces then aspirated by ultrasonic vibration Receives: Procedure: Divide and conquer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal edema preoperative
Central corneal thickness measurements were taken preoperatively
Measured: Day 1
Secondary outcomes (1)
Corneal edema postoperative
Central corneal thickness measurements were taken postoperative day 4
Measured: Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study startJan 2015
- Primary completionJul 2015
- Study completionDec 2015
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
- Other
- Time perspective
- Prospective
- Enrolment
- 96 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
- NCT03689270
- Sponsor's protocol ID
- 2015-12Obs-CHMRT
- Acronym
- COPHA
- Status last verified
- Aug 2018
- First submitted
- 25 Sep 2018
- Last updated
- 28 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 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Corneal Thickness Assessment After Phacoemulsification: Subluxation Versus Divide-and-Conquer
- ClinicalTrials.gov ID
- NCT03689270
- Acronym / sponsor ID
- COPHA / 2015-12Obs-CHMRT
- Conditions
- Cataract
- Keywords
- subluxation, Divide and conquer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 28 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 compare the impact of two phacoemulsification techniques (subluxation versus divide-and-conquer) on postoperative corneal edema at postoperative hour 1 and day 4.
Detailed description
Phacoemulsification is the procedure of choice for most surgeons performing cataract surgery. Alternative techniques have been in development over the last twenty years, with the hope of optimizing operating times, total ultrasound energy used, patient safety, patient satisfaction and visual recovery associated with cataract surgery.
Divide-and conquer is the parent nucleofracture technique.The subluxation technique is a newer technique that is less frequently used because of an increased risk of corneal endothelium damage.
The aim of this comparative study was to evaluate corneal edema immediately after surgery performed with the subluxation technique versus divide-and-conquer. Corneal edema was determined by measuring central corneal thickness (CCT).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subluxation | – | Procedure: SubluxationNucleus is hydrodissected until it lilts above the capsular bag, rotated to face the incision then tumbled and emulsification continues from the opposite equator outside in until complete |
| Divide and Conquer | – | Procedure: Divide and conquerCataract nucleus is fragmented into 4 pieces then aspirated by ultrasonic vibration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients underwent phacoemulsification cataract surgery over a 6-month period.
Key inclusion criteria (2 listed)
- The presence of a senile cataract with equivalent grades and history of visual acuity regression
- Informed written consent
Key exclusion criteria (3 listed)
- Patients with total white cataract
- With history of ocular surgery and other eye diseases (corneal pathology, uveitis, glaucoma)
- With systemic diseases with the potential to affect vision
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 |
|---|---|---|
| SubluxationOne pole of The nucleus is hydrodissected until it lilts above the capsular bag. The tilted nucleus is rotated to face the incision and remaining half nucleus is then tumbled and emulsification continues from the opposite equator outside in until complete. | Procedure or surgery | Subluxation |
| Divide and conquerCataract nucleus is fragmented into 4 pieces then aspirated by ultrasonic vibration | Procedure or surgery | Divide and Conquer |
Primary outcome
Corneal edema preoperative
Time frame: Day 1
Central corneal thickness measurements were taken preoperatively
1 secondary outcome
Corneal edema postoperative
Time frame: Day 4
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 28 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 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: finished, as of the sponsor's last update on 28 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?
Corneal edema preoperative (time frame: Day 1). 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 28 Sep 2018; AzTrials last refreshed its copy on 27 Oct 2026.