CataractsPERCEPOLISNCT02535819
Endothelial Cell Loss After Phacoemulsification Intra and Supracapsular
A study testing Subluxation and Divide and Conquer in people with Cataracts, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial summary
Cataract is the clouding of the lens of the eye, which initially prevents clear vision and eventually progresses to blindness if left untreated. Cataract remains the leading cause of blindness and an important cause of visual impairment across the globe. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataracts
- What is being tested?
- Subluxation and Divide and Conquer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2015to May 2018
- 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
- Male or female aged ≥ 18 years
- Patients undergoing cataract surgery
- Visual acuity Monoyer scale <6/10e (< +0.2 logMar)
- Nuclear, cortical and posterior subcapsular cataract with normal density to severe in the LOCSIII classification
Who cannot join
- insulin-dependent diabetes and /or diabetic retinopathy
- corneal disease: keratitis, dystrophy, corneal degeneration
- Any disease of intraocular pressure
- Any disease of the anterior segment
- Low preoperative endothelial cell density < 1500 c/mm²
- Combined surgery (cataract + corneal transplant, cataract + glaucoma surgery, cataract +vitrectomy ...)
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- Risk factors for surgical per-operative complication
- Pregnancy, lactation
- Ward of court
- Patient not covered by the Social Security scheme
Trial locations and contacts
1 site in 1 country.
About this study
Cataract is the clouding of the lens of the eye, which initially prevents clear vision and eventually progresses to blindness if left untreated. Cataract remains the leading cause of blindness and an important cause of visual impairment across the globe. Cataract surgery by ultrasonic phacoemulsification is the most common surgery practiced in France (600 000/year)
Two sub-categories of phacoemulsification coexist :
Endocapsulars techniques represented by Divide-and-Conquer and Phaco-Chop ; and Supracapsular techniques mainly represented by Subluxation (similar to Tilt-and-Tumble) The corneal endothelium plays an important role in maintaining the dehydrated state and the transparency of the cornea. Some degree of endothelial cell loss invariably occurs in all types of cataract surgery but the amount of endothelial cell loss may varies with the type of surgical technique The aim of the study is to evaluate the density of the central corneal endothelial cells before and after cataract surgery comparing two phacoemulsification techniques (Divide-and-Conquer vs Subluxation)
- Conditions
- Cataracts
- Being tested
- Subluxation, Divide and Conquer
- Keywords
- Cataract surgery
- Medical subject headings
- Cataract
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 | Experimental | 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 | Other | 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.
Main Outcome Measures: postoperative Endothelial cell loss of the central corneal
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2015 (estimated)
- Study startJun 2015
- Primary completionSep 2017
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CataractsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 294 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02535819
- Sponsor's protocol ID
- 2015-01-CHRMT
- Other IDs
- 2015-A00789-40
- Acronym
- PERCEPOLIS
- Status last verified
- Sep 2017
- First submitted
- 30 Jun 2015
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Perone JM, Ghetemme C, Zevering Y, Zaidi M, Ouamara N, Goetz C, Lhuillier L. Corneal Endothelial Cell Loss After Endocapsular and Supracapsular Phacoemulsification: The PERCEPOLIS Randomized Clinical Trial. Cornea. 2022 Jun 1;41(6):714-721. doi: 10.1097/ICO.0000000000002822. Epub 2021 Nov 2.
PubMed 34732666Leterrier J, Mastrangelo L, Goetz C, Zevering Y, Perone JM. Preoperative and perioperative factors that predict endothelial cell loss 1 year after uncomplicated Descemet membrane endothelial keratoplasty. PLoS One. 2025 Dec 19;20(12):e0339346. doi: 10.1371/journal.pone.0339346. eCollection 2025.
PubMed 41417772
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Cell Loss After Phacoemulsification Intra and Supracapsular
- ClinicalTrials.gov ID
- NCT02535819
- Acronym / sponsor ID
- PERCEPOLIS / 2015-01-CHRMT
- Conditions
- Cataracts
- Keywords
- Cataract surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 31 Aug 2015 (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.
Cataract is the clouding of the lens of the eye, which initially prevents clear vision and eventually progresses to blindness if left untreated. Cataract remains the leading cause of blindness and an important cause of visual impairment across the globe. Cataract surgery by ultrasonic phacoemulsification is the most common surgery practiced in France (600 000/year)
Two sub-categories of phacoemulsification coexist :
Endocapsulars techniques represented by Divide-and-Conquer and Phaco-Chop ; and Supracapsular techniques mainly represented by Subluxation (similar to Tilt-and-Tumble) The corneal endothelium plays an important role in maintaining the dehydrated state and the transparency of the cornea. Some degree of endothelial cell loss invariably occurs in all types of cataract surgery but the amount of endothelial cell loss may varies with the type of surgical technique The aim of the study is to evaluate the density of the central corneal endothelial cells before and after cataract surgery comparing two phacoemulsification techniques (Divide-and-Conquer vs Subluxation)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subluxation | Experimental | 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 | Other | 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
Key inclusion criteria (4 listed)
- Male or female aged ≥ 18 years
- Patients undergoing cataract surgery
- Visual acuity Monoyer scale <6/10e (< +0.2 logMar)
- Nuclear, cortical and posterior subcapsular cataract with normal density to severe in the LOCSIII classification
Key exclusion criteria (10 listed)
- insulin-dependent diabetes and /or diabetic retinopathy
- corneal disease: keratitis, dystrophy, corneal degeneration
- Any disease of intraocular pressure
- Any disease of the anterior segment
- Low preoperative endothelial cell density < 1500 c/mm²
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
Main Outcome Measures: postoperative Endothelial cell loss of the central corneal
Time frame: 12 month
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 Jun 2026.
- Results publication: PubMed 34732666Perone JM, Ghetemme C, Zevering Y, Zaidi M, Ouamara N, Goetz C, Lhuillier L. Corneal Endothelial Cell Loss After Endocapsular and Supracapsular Phacoemulsification: The PERCEPOLIS Randomized Clinical Trial. Cornea. 2022 Jun 1;41(6):714-721. doi: 10.1097/ICO.0000000000002822. Epub 2021 Nov 2.
- Derived from this study: PubMed 41417772Leterrier J, Mastrangelo L, Goetz C, Zevering Y, Perone JM. Preoperative and perioperative factors that predict endothelial cell loss 1 year after uncomplicated Descemet membrane endothelial keratoplasty. PLoS One. 2025 Dec 19;20(12):e0339346. doi: 10.1371/journal.pone.0339346. eCollection 2025.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subluxation and Divide and Conquer in people with Cataracts, 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 4 inclusion and 10 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 Jun 2026. 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?
Main Outcome Measures: postoperative Endothelial cell loss of the central corneal (time frame: 12 month). 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 NCT02535819, which also lists 2 linked publications.
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 Jun 2026.