Fuchs Endothelial Corneal DystrophySUCCESSNCT07265388
SUCCESS Score Validation in Fuchs Dystrophy
An observational study of Fuchs Endothelial Corneal Dystrophy, run by Instituto Ramón y Cajal de Investigación Sanitaria at 1 site in Spain.
Trial summary
This prospective multicenter diagnostic study aims to externally validate and extend the SUCCESS Score for predicting the need for endothelial keratoplasty after cataract surgery in patients with Fuchs endothelial corneal dystrophy (FECD). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Fuchs Endothelial Corneal Dystrophy
- What is being tested?
- Phacoemulsification Cataract Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2020to Dec 2026
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: dults with clinically diagnosed Fuchs endothelial corneal dystrophy (FECD) and visually significant cataract who are scheduled to undergo phacoemulsification surgery at participating tertiary referral centers in Spain. Eligible participants present FECD grade ≥2 on the modified Krachmer scale and have available preoperative Scheimpflug tomography and corneal densitometry measurements. The study population represents a real-world clinical cohort of patients routinely evaluated in corneal and cataract units, allowing assessment of the predictive performance and clinical utility of the SUCCESS Score under standard care conditions.
Who may be able to join
- Adults aged ≥40 years.
- Clinical diagnosis of Fuchs endothelial corneal dystrophy (FECD) grade ≥2 on the modified Krachmer scale.
- Presence of visually significant cataract requiring phacoemulsification surgery.
- Ability to provide informed consent and comply with study procedures.
- Availability of preoperative Scheimpflug tomography and corneal densitometry measurements.
Who cannot join
- Epithelial or stromal edema precluding reliable corneal imaging.
- Previous ocular surgery (including corneal or intraocular procedures).
- Corneal trauma, infection, or inflammation affecting endothelial integrity.
- Coexisting ocular pathologies that could confound postoperative assessment (e.g., advanced glaucoma, macular degeneration).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Ramón y Cajal, Universidad de Alcalá, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS)
Madrid, Madrid, 28034
Francisco Arnalich Montiel, PhD, +34 913368853, francisco.arnalich@salud.madrid.org
David Mingo-Botin, PhD, +34 913368853, david.mingo@salud.madrid.org
About this study
Official title: Validation and Extension of the SUCCESS Score for Fuchs Dystrophy After Cataract Surgery
This prospective multicenter diagnostic study aims to externally validate and extend the SUCCESS Score for predicting the need for endothelial keratoplasty after cataract surgery in patients with Fuchs endothelial corneal dystrophy (FECD). The model's performance and clinical utility are assessed using discrimination, calibration, and reclassification metrics.
Read the detailed description
Fuchs endothelial corneal dystrophy (FECD) is a progressive corneal disorder characterized by endothelial cell loss, corneal edema, and visual impairment. In patients with FECD and cataract, an important clinical challenge is to predict whether cataract surgery alone will suffice or whether endothelial keratoplasty (EK) will be required postoperatively. Accurate preoperative risk stratification is essential for surgical planning and patient counseling.
The SUCCESS Score, derived from Scheimpflug tomography, was proposed as an objective index to estimate the risk of postoperative corneal decompensation in FECD. However, its external multicenter validation and the potential contribution of corneal densitometry have not yet been fully established.
This ongoing prospective, observational, multicenter study aims to externally validate and extend the SUCCESS Score for predicting the need for EK after cataract surgery in patients with FECD. The study is being conducted across five tertiary referral centers in Spain. Eligible participants are adults with FECD grade ≥2 on the modified Krachmer scale and a visually significant cataract requiring phacoemulsification. Patients with epithelial edema, prior ocular surgery, corneal infection, or trauma are excluded.
Preoperative evaluation includes Scheimpflug tomography and corneal densitometry analysis. The primary outcome is the requirement for endothelial keratoplasty after cataract surgery, determined by postoperative visual function and corneal evaluation. Model performance will be assessed through discrimination (Harrell's C statistic), calibration, reclassification (IDI, NRI), and decision curve analysis to estimate clinical utility.
The primary analysis is scheduled for completion in October 2024. Extended follow-up will continue until June 25, 2026, to assess long-term predictive performance and generalizability of the extended SUCCESS model.
An interactive web-based calculator implementing both the original and extended SUCCESS models will be provided as a supplementary tool to facilitate clinical use and standardized patient counseling across participating centers.
- Conditions
- Fuchs Endothelial Corneal Dystrophy
- Being tested
- Phacoemulsification Cataract Surgery
- Keywords
- Fuchs Endothelial Corneal Dystrophy, Cataract Surgery, endothelial keratoplasty, Diagnostic Accuracy, Prognostic Validation, Predictive Modeling
- Medical subject headings
- Fuchs' Endothelial Dystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phacoemulsification Cataract SurgeryProcedure or surgery
Standard phacoemulsification cataract surgery performed in patients with Fuchs endothelial corneal dystrophy (FECD). All procedures are carried out according to institutional protocols at participating tertiary centers. Preoperative Scheimpflug tomography and corneal densitometry measurements are collected to calculate the SUCCESS Score and evaluate the risk of postoperative endothelial decompensation. Postoperative outcomes are monitored to determine whether endothelial keratoplasty (EK) is required during follow-up.
| Study group | Role | What they receive |
|---|---|---|
| FECD Cohort | Patients with clinically diagnosed Fuchs endothelial corneal dystrophy (FECD) undergoing phacoemulsification cataract surgery at participating tertiary centers. All participants receive standard cataract surgery, and their preoperative data are used to calculate the SUCCESS Score with and without corneal densitometry parameters. Postoperative outcomes are monitored to determine the need for endothelial keratoplasty (EK). Receives: Procedure: Phacoemulsification Cataract Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for endothelial keratoplasty (EK) after cataract surgery in patients with Fuchs endothelial corneal dystrophy
The primary outcome is the need for endothelial keratoplasty (EK) following phacoemulsification cataract surgery in patients with Fuchs endothelial corneal dystrophy (FECD). The endpoint is determined based on postoperative best-corrected visual acuity, corneal clarity, and presence of clinical signs of corneal decompensation. Each eye is evaluated using standardized follow-up visits and imaging criteria across participating centers. The decision to perform EK is made according to established clinical indications by the attending ophthalmologist, ensuring consistency across study sites.
Measured: Up to 36 months after cataract surgery
Secondary outcomes (3)
Model discrimination (Harrell's C statistic) of the SUCCESS Score
Model discrimination will be assessed using Harrell's C statistic (concordance index) to quantify how accurately the SUCCESS Score predicts the need for endothelial keratoplasty after cataract surgery in patients with FECD.
Measured: At primary analysis (October 2024)
Calibration and predictive accuracy of the SUCCESS Score
Calibration plots and Brier score will be used to evaluate the agreement between predicted and observed probabilities of endothelial keratoplasty. Goodness-of-fit will be assessed across deciles of predicted risk.
Measured: At primary analysis (June 2026)
Reclassification and clinical utility of the extended SUCCESS model
The incremental value of adding corneal densitometry to the SUCCESS Score will be assessed using Integrated Discrimination Improvement (IDI), Net Reclassification Improvement (NRI), and Decision Curve Analysis (DCA) to determine potential clinical benefit.
Measured: At primary analysis (June 2026)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start1 Jun 2020
- Primary completionJul 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fuchs Endothelial Corneal DystrophyStudies 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
- 250 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Instituto Ramón y Cajal de Investigación Sanitaria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Arnalich-Montiel, Instituto Ramón y Cajal de Investigación Sanitaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07265388
- Sponsor's protocol ID
- SUCCESS-FUCHS
- Other IDs
- PI22/01252
- Acronym
- SUCCESS
- Status last verified
- Nov 2025
- First submitted
- 24 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data (IPD) that underlie the results reported in this article will be made available to qualified researchers upon reasonable request. Access will be granted after publication of the primary results and upon approval of a methodologically sound proposal. Data will be shared through a secure institutional platform of the Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS).
Publications
Arnalich-Montiel F, de-Arriba-Palomero P, Muriel A, Mingo-Botin D. A Risk Prediction Model for Endothelial Keratoplasty After Uncomplicated Cataract Surgery in Fuchs Endothelial Corneal Dystrophy. Am J Ophthalmol. 2021 Nov;231:70-78. doi: 10.1016/j.ajo.2021.04.016. Epub 2021 May 2.
PubMed 33951443
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Extension of the SUCCESS Score for Fuchs Dystrophy After Cataract Surgery
- ClinicalTrials.gov ID
- NCT07265388
- Acronym / sponsor ID
- SUCCESS / SUCCESS-FUCHS
- Conditions
- Fuchs Endothelial Corneal Dystrophy
- Keywords
- Fuchs Endothelial Corneal Dystrophy, Cataract Surgery, endothelial keratoplasty, Diagnostic Accuracy, Prognostic Validation, Predictive Modeling
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Instituto Ramón y Cajal de Investigación SanitariaUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 Dec 2025 (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 prospective multicenter diagnostic study aims to externally validate and extend the SUCCESS Score for predicting the need for endothelial keratoplasty after cataract surgery in patients with Fuchs endothelial corneal dystrophy (FECD). The model's performance and clinical utility are assessed using discrimination, calibration, and reclassification metrics.
Detailed description
Fuchs endothelial corneal dystrophy (FECD) is a progressive corneal disorder characterized by endothelial cell loss, corneal edema, and visual impairment. In patients with FECD and cataract, an important clinical challenge is to predict whether cataract surgery alone will suffice or whether endothelial keratoplasty (EK) will be required postoperatively. Accurate preoperative risk stratification is essential for surgical planning and patient counseling.
The SUCCESS Score, derived from Scheimpflug tomography, was proposed as an objective index to estimate the risk of postoperative corneal decompensation in FECD. However, its external multicenter validation and the potential contribution of corneal densitometry have not yet been fully established.
This ongoing prospective, observational, multicenter study aims to externally validate and extend the SUCCESS Score for predicting the need for EK after cataract surgery in patients with FECD. The study is being conducted across five tertiary referral centers in Spain. Eligible participants are adults with FECD grade ≥2 on the modified Krachmer scale and a visually significant cataract requiring phacoemulsification. Patients with epithelial edema, prior ocular surgery, corneal infection, or trauma are excluded.
Preoperative evaluation includes Scheimpflug tomography and corneal densitometry analysis. The primary outcome is the requirement for endothelial keratoplasty after cataract surgery, determined by postoperative visual function and corneal evaluation. Model performance will be assessed through discrimination (Harrell's C statistic), calibration, reclassification (IDI, NRI), and decision curve analysis to estimate clinical utility.
The primary analysis is scheduled for completion in October 2024. Extended follow-up will continue until June 25, 2026, to assess long-term predictive performance and generalizability of the extended SUCCESS model.
An interactive web-based calculator implementing both the original and extended SUCCESS models will be provided as a supplementary tool to facilitate clinical use and standardized patient counseling across participating centers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FECD Cohort | – | Procedure: Phacoemulsification Cataract SurgeryPatients with clinically diagnosed Fuchs endothelial corneal dystrophy (FECD) undergoing phacoemulsification cataract surgery at participating tertiary centers. All participants receive standard cataract surgery, and their preoperative data are used to calculate the SUCCESS Score with and without corneal densitometry parameters. Postoperative outcomes are monitored to determine the need for endothelial keratoplasty (EK). |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- dults with clinically diagnosed Fuchs endothelial corneal dystrophy (FECD) and visually significant cataract who are scheduled to undergo phacoemulsification surgery at participating tertiary referral centers in Spain. Eligible participants present FECD grade ≥2 on the modified Krachmer scale and have available preoperative Scheimpflug tomography and corneal densitometry measurements. The study population represents a real-world clinical cohort of patients routinely evaluated in corneal and cataract units, allowing assessment of the predictive performance and clinical utility of the SUCCESS Score under standard care conditions.
Key inclusion criteria (5 listed)
- Adults aged ≥40 years.
- Clinical diagnosis of Fuchs endothelial corneal dystrophy (FECD) grade ≥2 on the modified Krachmer scale.
- Presence of visually significant cataract requiring phacoemulsification surgery.
- Ability to provide informed consent and comply with study procedures.
- Availability of preoperative Scheimpflug tomography and corneal densitometry measurements.
Key exclusion criteria (4 listed)
- Epithelial or stromal edema precluding reliable corneal imaging.
- Previous ocular surgery (including corneal or intraocular procedures).
- Corneal trauma, infection, or inflammation affecting endothelial integrity.
- Coexisting ocular pathologies that could confound postoperative assessment (e.g., advanced glaucoma, macular degeneration).
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 |
|---|---|---|
| Phacoemulsification Cataract SurgeryStandard phacoemulsification cataract surgery performed in patients with Fuchs endothelial corneal dystrophy (FECD). All procedures are carried out according to institutional protocols at participating tertiary centers. Preoperative Scheimpflug tomography and corneal densitometry measurements are collected to calculate the SUCCESS Score and evaluate the risk of postoperative endothelial decompensation. Postoperative outcomes are monitored to determine whether endothelial keratoplasty (EK) is required during follow-up. | Procedure or surgery | FECD Cohort |
Primary outcome
Need for endothelial keratoplasty (EK) after cataract surgery in patients with Fuchs endothelial corneal dystrophy
Time frame: Up to 36 months after cataract surgery
The primary outcome is the need for endothelial keratoplasty (EK) following phacoemulsification cataract surgery in patients with Fuchs endothelial corneal dystrophy (FECD). The endpoint is determined based on postoperative best-corrected visual acuity, corneal clarity, and presence of clinical signs of corneal decompensation. Each eye is evaluated using standardized follow-up visits and imaging criteria across participating centers. The decision to perform EK is made according to established clinical indications by the attending ophthalmologist, ensuring consistency across study sites.
3 secondary outcomes
Model discrimination (Harrell's C statistic) of the SUCCESS Score
Time frame: At primary analysis (October 2024)
Calibration and predictive accuracy of the SUCCESS Score
Time frame: At primary analysis (June 2026)
Reclassification and clinical utility of the extended SUCCESS model
Time frame: At primary analysis (June 2026)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Results publication: PubMed 33951443Arnalich-Montiel F, de-Arriba-Palomero P, Muriel A, Mingo-Botin D. A Risk Prediction Model for Endothelial Keratoplasty After Uncomplicated Cataract Surgery in Fuchs Endothelial Corneal Dystrophy. Am J Ophthalmol. 2021 Nov;231:70-78. doi: 10.1016/j.ajo.2021.04.016. Epub 2021 May 2.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data (IPD) that underlie the results reported in this article will be made available to qualified researchers upon reasonable request. Access will be granted after publication of the primary results and upon approval of a methodologically sound proposal. Data will be shared through a secure institutional platform of the Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS).
Related trials for Fuchs Endothelial Corneal Dystrophy
RecruitingPhase 2
Study of EO2002 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction
Corneal Edema, Fuchs
RecruitingPhase 2
DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy
Fuchs Endothelial Corneal Dystrophy, Fuchs
Active, not recruiting
The Belgian Endothelial Surgical Transplant of the Cornea
Corneal Edema, Corneal Endothelial Disorder
Enrolling by invitationObservational study
The Effect of Topical Rho-kinase Inhibitors on Corneas of Patients With Fuchs Endothelial Corneal Dystrophy
Fuchs Endothelial Corneal Dystrophy, Cataract
RecruitingPhase 2
Targeting Reactive Oxygen Species Production as a Novel Therapeutic in Fuch's Endothelial Corneal Dystrophy
Fuchs Endothelial Corneal Dystrophy
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.
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 Fuchs Endothelial Corneal Dystrophy, run by Instituto Ramón y Cajal de Investigación Sanitaria at 1 site in Spain.
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 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: looking for participants now, as of the sponsor's last update on 4 Dec 2025. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francisco Arnalich-Montiel, PhD (+34 913368853, francisco.arnalich@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for endothelial keratoplasty (EK) after cataract surgery in patients with Fuchs endothelial corneal dystrophy (time frame: Up to 36 months after cataract surgery). 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 NCT07265388, which also lists 1 linked publication.
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 4 Dec 2025; AzTrials last refreshed its copy on 29 Oct 2026.