CataractPREDICSNCT05265832
Influencing Factors of the Corneal Endothelial Cell Loss
A study testing Phacoemulsification in people with Cataract, run by Centre Hospitalier Régional Metz-Thionville at 2 sites in France.
Trial summary
This is a multi-center cohort study with prognostic aims to identify factors associated with endothelial cell loss during cataract surgery. Patients will have their endothelial density measured by specular microscopy preoperatively, at 1 month and at 3 months after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Phacoemulsification
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 2 sitesFrance
- Study dates
- 4 May 2022to 4 Sep 2023
- 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
- 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
2 sites in 1 country.
France2 sites
CHR Metz-Thionville/Hopital Mercy
Metz, Grand Est, 57085
CHR Metz-Thionville_Hopital Bel Air
Thionville, Grand Est
About this study
Official title: Identification of Factors That Influence the Corneal Endothelial Cell Loss During Phacoemulsification
This is a multi-center cohort study with prognostic aims to identify factors associated with endothelial cell loss during cataract surgery.
Patients will have their endothelial density measured by specular microscopy preoperatively, at 1 month and at 3 months after surgery. The rest of their management will be in line with standard practice.
Read the detailed description
Cataract surgery is the most commonly performed surgical procedure worldwide. Postoperative visual function depends on implant into the crystalline lens, retinal lesion, corneal damage or glaucomatous damage. Moreover, preoperative corneal endothelial damage should be as low as possible to provide corneal transparency. Indeed, the endothelium plays important role in maintaining corneal transparency.
The loss rate of endothelial cell after cataract surgery ranges in the scientific literature from 8 to 15 %. Severe endothelial cell loss contributes to corneal edema. This edema resulting in a loss of visual acuity and may require corneal transplantation as a last resort.
Various studies describe some factors that affecting endothelial cell loss such as the cataract density, pupil abnormalities (small diameter), Advanced age or short axial length.
However, few studies have been demonstrated the link between endothelial cell loss and the volume of fluid used during the intervention or the use of intracamerular substances. This study wants to establish a correlation between endothelial cell loss and predictive factors. Thus, knowledge of these factors would have ensured a better control of endothelial dysfunction.
- Conditions
- Cataract
- Being tested
- Phacoemulsification
- Keywords
- Endothelial cell loss
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhacoemulsificationProcedure or surgery
Endocapsular technique (Divide-and-conquer) and supracapsular technique (Subluxation) will be used equally.
| Study group | Role | What they receive |
|---|---|---|
| Cataract surgery | Experimental | Phacoemulsification cataract surgery Receives: Procedure: Phacoemulsification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative endothelial cell loss
Difference in endothelial cell density between preoperative measurements and 3 months after surgery
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start4 May 2022
- Primary completion17 Oct 2022
- Study completion4 Sep 2023
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 154 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, MD, Principal investigator, CHR Metz Thionville Hopital de Mercy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265832
- Sponsor's protocol ID
- 2021-04-CHRMT
- Acronym
- PREDICS
- Status last verified
- Nov 2023
- First submitted
- 23 Feb 2022
- Last updated
- 26 Dec 2023
- 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 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Factors That Influence the Corneal Endothelial Cell Loss During Phacoemulsification
- ClinicalTrials.gov ID
- NCT05265832
- Acronym / sponsor ID
- PREDICS / 2021-04-CHRMT
- Conditions
- Cataract
- Keywords
- Endothelial cell loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 4 May 2022 (actual)
- Primary completion
- 17 Oct 2022 (actual)
- Study completion
- 4 Sep 2023 (actual)
- First posted
- 4 Mar 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.
This is a multi-center cohort study with prognostic aims to identify factors associated with endothelial cell loss during cataract surgery.
Patients will have their endothelial density measured by specular microscopy preoperatively, at 1 month and at 3 months after surgery. The rest of their management will be in line with standard practice.
Detailed description
Cataract surgery is the most commonly performed surgical procedure worldwide. Postoperative visual function depends on implant into the crystalline lens, retinal lesion, corneal damage or glaucomatous damage. Moreover, preoperative corneal endothelial damage should be as low as possible to provide corneal transparency. Indeed, the endothelium plays important role in maintaining corneal transparency.
The loss rate of endothelial cell after cataract surgery ranges in the scientific literature from 8 to 15 %. Severe endothelial cell loss contributes to corneal edema. This edema resulting in a loss of visual acuity and may require corneal transplantation as a last resort.
Various studies describe some factors that affecting endothelial cell loss such as the cataract density, pupil abnormalities (small diameter), Advanced age or short axial length.
However, few studies have been demonstrated the link between endothelial cell loss and the volume of fluid used during the intervention or the use of intracamerular substances. This study wants to establish a correlation between endothelial cell loss and predictive factors. Thus, knowledge of these factors would have ensured a better control of endothelial dysfunction.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cataract surgery | Experimental | Procedure: PhacoemulsificationPhacoemulsification cataract surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| PhacoemulsificationEndocapsular technique (Divide-and-conquer) and supracapsular technique (Subluxation) will be used equally. | Procedure or surgery | Cataract surgery |
Primary outcome
Postoperative endothelial cell loss
Time frame: Month 3
Difference in endothelial cell density between preoperative measurements and 3 months after 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 26 Dec 2023.
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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, MD principal investigator
CHR Metz Thionville Hopital de Mercy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phacoemulsification in people with Cataract, run by Centre Hospitalier Régional Metz-Thionville at 2 sites 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 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Postoperative endothelial cell loss (time frame: Month 3). 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 Dec 2023.