Endothelial Cell Loss, CornealPREDICSPILOTNCT05529485
Quantification of Factors Influencing Endothelial Damage During Phacoemulsification
An observational study of Endothelial Cell Loss, Corneal and Cataract, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial summary
The aim of this study is to determine the principal factors that influence endothelial cell loss three month post cataract surgery. Methods: Multi center observational Cohort study, inclusion period from 12/01/2022 to 10/06/2022. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endothelial Cell Loss, Corneal, Cataract, Phacoemulsification
- What is being tested?
- Cataract surgery by phacoemulsification
- Type of treatment
- Surgery or procedure
- How many people
- 121 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jan 2022to 1 Aug 2022
- 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 undergoing cataract surgery
Who may be able to join
- Patients undergoing cataract surgery
- Visual acuity monoyer scale <8/10e (> +0.2 logMar)
- Nuclear, cortical and posterior subcapsular cataract with normal density to severe in the LOCSIII classification
- Covered by the social security scheme
- Have given their oral agreement
Who cannot join
- Corneal disease: keratitis, dystrophy or corneal degeneration
- Any disease of the anterior segment
- Low preoperative endothelial cell density <1000 c/mm²
- Pregnancy, lactation
- Risk factors for surgical per-operative complication
- Uncontrolled ocular pressure
- Combined surgery (cataract with corneal graft, cataract with glaucoma surgery, cataract with vitrectomy, ....)
- Under legal protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Research and Quantification of Factors Influencing Endothelial Damage During Phacoemulsification
The aim of this study is to determine the principal factors that influence endothelial cell loss three month post cataract surgery.
Methods: Multi center observational Cohort study, inclusion period from 12/01/2022 to 10/06/2022. One hundred and seventy-five eyes of hundred and four patients who have appointment for cataract surgical indication were included. The percentage of corneal endothelial cell loss was quantified using specular microscopy before and 3 months after the surgery.
Read more
14 variables (pre-operative and intra-operative) that could be associated to endothelial cell injury were selected.
A bivariate analysis of relationship between these factors and endothelial cell loss at 3 months was performed by simple linear regression (Wilcoxon and Fischer tests). Multivariate analysis was performed by multiple linear regression in order to identify the factors independently related to endothelial cell loss.
- Being tested
- Cataract surgery by phacoemulsification
- Medical subject headings
- Corneal Endothelial Cell Loss, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract surgery by phacoemulsificationProcedure or surgery
Cataract surgery by phacoemulsification
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in central corneal endothelial cell density (cells/mm²) between the 1st preoperative measurement and the postoperative measurement at 3 months.
Specular counts were performed by the orthoptists, residents or physicians of the department using a Nidek CEM-530 specular microscope with automated central cell counting without corneal contact. Three measurements were performed at each consultation and the average of these three measurements was reported.
Measured: 3 months after cataract surgery
Secondary outcomes (2)
Postoperative visual acuity
best spectacle corrected visual acuity is evaluated using Monoyer scale, scores ranging from 1 to 10, higher scores mean a better outcome; score 10 is the best.
Measured: 3 months after cataract surgery
Postoperative corneal edema
Corneal edema is measured using specular microscope with pachymeter
Measured: 3 months after cataract surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start12 Jan 2022
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial Cell Loss, CornealStudies 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
- Retrospective
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Marc Perone, Principal investigator, CHR Metz Thionville Hopital de Mercy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529485
- Sponsor's protocol ID
- 2022-11Obs-CHRMT
- Acronym
- PREDICSPILOT
- Status last verified
- Sep 2022
- First submitted
- 2 Sep 2022
- Last updated
- 10 Sep 2022
- 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 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research and Quantification of Factors Influencing Endothelial Damage During Phacoemulsification
- ClinicalTrials.gov ID
- NCT05529485
- Acronym / sponsor ID
- PREDICSPILOT / 2022-11Obs-CHRMT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 7 Sep 2022 (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 aim of this study is to determine the principal factors that influence endothelial cell loss three month post cataract surgery.
Methods: Multi center observational Cohort study, inclusion period from 12/01/2022 to 10/06/2022. One hundred and seventy-five eyes of hundred and four patients who have appointment for cataract surgical indication were included. The percentage of corneal endothelial cell loss was quantified using specular microscopy before and 3 months after the surgery.
14 variables (pre-operative and intra-operative) that could be associated to endothelial cell injury were selected.
A bivariate analysis of relationship between these factors and endothelial cell loss at 3 months was performed by simple linear regression (Wilcoxon and Fischer tests). Multivariate analysis was performed by multiple linear regression in order to identify the factors independently related to endothelial cell loss.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cataract surgery
Key inclusion criteria (5 listed)
- Patients undergoing cataract surgery
- Visual acuity monoyer scale <8/10e (> +0.2 logMar)
- Nuclear, cortical and posterior subcapsular cataract with normal density to severe in the LOCSIII classification
- Covered by the social security scheme
- Have given their oral agreement
Key exclusion criteria (8 listed)
- Corneal disease: keratitis, dystrophy or corneal degeneration
- Any disease of the anterior segment
- Low preoperative endothelial cell density <1000 c/mm²
- Pregnancy, lactation
- Risk factors for surgical per-operative complication
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 |
|---|---|---|
| Cataract surgery by phacoemulsificationCataract surgery by phacoemulsification | Procedure or surgery | – |
Primary outcome
The difference in central corneal endothelial cell density (cells/mm²) between the 1st preoperative measurement and the postoperative measurement at 3 months.
Time frame: 3 months after cataract surgery
Specular counts were performed by the orthoptists, residents or physicians of the department using a Nidek CEM-530 specular microscope with automated central cell counting without corneal contact. Three measurements were performed at each consultation and the average of these three measurements was reported.
2 secondary outcomes
Postoperative visual acuity
Time frame: 3 months after cataract surgery
Postoperative corneal edema
Time frame: 3 months after cataract surgery
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 10 Sep 2022.
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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.
Jean Marc Perone principal investigator
CHR Metz Thionville Hopital de Mercy
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 Endothelial Cell Loss, Corneal and Cataract, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
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 5 inclusion and 8 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 10 Sep 2022. 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 France. 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?
The difference in central corneal endothelial cell density (cells/mm²) between the 1st preoperative measurement and the postoperative measurement at 3 months. (time frame: 3 months after cataract surgery). 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 10 Sep 2022.