CataractPROFIDENCT07441616
Partial Range Of Field IOLs in DMEK-Enabled Procedures
A study testing combined cataract and lamellar endothelial keratoplasty in people with Cataract and Fuchs Endothelial Corneal Dystrophy, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
Study Overview This study aims to evaluate the visual outcomes, quality of vision, and patient satisfaction after receiving an extended range PRoF intraocular lens (IOL) during triple Descemet Membrane Endothelial Keratoplasty (DMEK) surgery. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Cataract, Fuchs Endothelial Corneal Dystrophy
- What is being tested?
- combined cataract and lamellar endothelial keratoplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2026to Sep 2028
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with bilateral cataract grade greater than II, according to the Lens Opacities Classification System III (LOCS III) , combined with FECD displaying clinical or subclinical corneal edema or displaying visual disturbing guttae with at least Krachmer grade 3
- Patients aged between 40 and 90 years
- Capacity to read and to understand the study information and to provide informed consent, as well as Patient Reported Spectacle Independence Questionnaire (PRSIQ) and Patient Reported Visual Symptom Questionnaire (PRVSQ)
- Patients willing and capable to attend the 6-month follow-up appointment
Who cannot join
- history of ocular surgery
- corneal scars
- macular disease revealed by pre-surgical macular Optical Coherence Tomography (OCT),
- opticopathy
- glaucoma with reduced sensitivity of visual field
- uveitis
Show all 13Show fewer
- amblyopia
- axial length <22mm or >25mm,
- scotopic pupil size >5mm,
- central corneal thickness >700microns,
- corneal astigmatism >1 diopters (D) on biometry
- irregular astigmatism (RMS HOA 3mm pupil >0.3)
- angle kappa >0.3mm ((chord µ measured with Pentacam HR; Oculus, Wetzlar, Germany)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site
University Hospital Leuven
Leuven, 3000
Heleen Delbeke, MD, PhD, +3216332370, heleen.delbeke@uzleuven.be
About this study
Official title: A Feasibility Study Evaluating Visual Outcomes of Extended Partial Range of Field Refractive Intraocular Lenses in Patients Undergoing Combined Cataract Surgery and Descemet Membrane Endothelial Keratoplasty (Triple DMEK)
Study Overview
This study aims to evaluate the visual outcomes, quality of vision, and patient satisfaction after receiving an extended range PRoF intraocular lens (IOL) during triple Descemet Membrane Endothelial Keratoplasty (DMEK) surgery. This surgery is typically performed to treat patients with both corneal endothelial dysfunction and cataracts. By testing a newer IOL, the PureSee™ extended PRoF IOL, this study hopes to improve the way ophthalmologists plan surgeries and select IOLs for these patients, ultimately helping surgeons optimize the results and expand the options available for people undergoing this procedure.
Read more
Purpose of the Study
The goal of this study is to evaluate how well the PureSee™ IOL works in terms of intermediate visual acuity (how well participants can see things at an arm's length). The investigators will also measure the quality of vision, satisfaction, and whether participants need glasses after surgery.
The investigators have set the following goals for this study:
Primary Goal:
To measure how well patients can see intermediate distances (uncorrected intermediate visual acuity, or UIVA) after receiving the PureSee™ IOL during triple DMEK surgery.
Secondary Goals:
To understand how independent patients are from glasses after surgery.
To measure patients' uncorrected and best-corrected visual acuity (sharpness of vision) at distance, intermediate, and near vision after surgery.
To evaluate the uncorrected defocus curve (how the vision of participants changes when focusing at different distances).
To measure contrast sensitivity (how well participants can see in low-light conditions or with subtle contrasts).
Who Can Join This Study?
To participate in this study, participants need to:
Be undergoing triple DMEK surgery for endothelial dysfunction and cataract at the time of enrollment.
Be eligible to receive an extended range of vision IOL as part of the procedure.
This study is looking for patients who are interested in understanding how new IOL technology might improve their postoperative vision quality and reduce their dependence on glasses.
What Will Happen During the Study?
Participants will have their visual outcomes and satisfaction measured at specific times following surgery. This includes:
Testing uncorrected and best-corrected visual acuity at several distances (distance, intermediate, and near).
Completing a survey about how satisfied they are with their vision and how often they need glasses or contact lenses.
Undergoing testing to measure contrast sensitivity (how well participants can see in low-light conditions).
Why Is This Study Important?
The results of this study will help doctors make better decisions about which IOLs to use during triple DMEK surgery. By evaluating the PureSee™ extended PRoF IOL, the investigators hope to expand options for patients and potentially improve visual outcomes and postoperative satisfaction. Ultimately, this study could help improve the quality of life for patients who have both cataracts and endothelial dysfunction.
Study Duration
Participants can expect to undergo their last assessment 6 months post-surgery to track their progress.
Read the detailed description
Detailed Study Description
This feasibility study is designed to evaluate the visual acuity, quality of vision, refractive outcomes, and patient satisfaction following the implantation of an extended range PRoF intraocular lens (IOL), specifically the PureSee™ IOL, during triple Descemet Membrane Endothelial Keratoplasty (DMEK) surgery. Triple DMEK is a combined procedure for patients with both corneal endothelial dysfunction and cataracts. The main goal of this study is to explore whether the PureSee™ IOL can improve visual outcomes and help reduce the need for glasses, ultimately improving the postoperative experience for these patients.
This study aims to provide valuable data on IOL selection and surgical planning for triple DMEK procedures. The findings will help expand the options available to patients and optimize their visual outcomes after surgery.
Study Objectives
The main objective of this study is to evaluate the visual outcomes, patient satisfaction, and overall success of PureSee™ IOL implantation in a clinical triple DMEK setting. The study will focus on the following specific goals:
Primary Objective
Uncorrected Intermediate Visual Acuity (UIVA):
To evaluate the uncorrected intermediate visual acuity (UIVA) achieved by the PureSee™ IOL in patients undergoing triple DMEK surgery. UIVA will be measured as the primary outcome.
Secondary Objectives
Spectacle Independence:
To assess patient-reported spectacle independence, meaning how often patients can go without glasses or contact lenses following triple DMEK surgery with PureSee™ IOL implantation.
Monocular Visual Acuity:
To measure monocular uncorrected and best-corrected distance, intermediate, and near visual acuity after surgery. This will help determine how well patients can see at various distances (far, near, and intermediate) both without correction (uncorrected) and with glasses or contact lenses (best corrected).
Defocus Curve:
To assess the uncorrected defocus curve, which measures how vision changes as patients focus on objects at different distances, from near to far. This curve helps characterize the range of vision patients experience with the IOL.
Contrast Sensitivity:
To evaluate contrast sensitivity, which tests the ability to see in low-light conditions or perceive subtle contrasts between objects, an important aspect of functional vision for everyday activities such as driving at night or reading.
Study Population
The study will include patients undergoing triple DMEK surgery for the treatment of both endothelial dysfunction and cataracts. Participants will be eligible to receive an extended range PRoF IOL, and must meet the inclusion criteria for the procedure. Specifically, the following criteria will apply:
Patients must be scheduled for triple DMEK surgery.
Patients must be willing to participate in the study and attend follow-up visits.
Study Design
This is a prospective, observational study. All patients will undergo triple DMEK surgery as part of routine clinical care, with the PureSee™ IOL being implanted during the procedure. The study will monitor patients' visual outcomes over several months following surgery.
Interventions
Intervention Group: Patients undergoing triple DMEK surgery will receive the PureSee™ IOL (extended range PRoF IOL).
Outcome Measures
The following primary and secondary outcome measures will be used to evaluate the effectiveness and impact of the PureSee™ IOL:
Primary Outcome
Uncorrected Intermediate Visual Acuity (UIVA): This will be measured at a defined postoperative time point.
Secondary Outcomes
Spectacle Independence: Assessed by patient-reported questionnaires regarding their use of glasses or contact lenses after surgery.
Monocular Visual Acuity:
Uncorrected distance, intermediate, and near visual acuity will be measured for both eyes at multiple postoperative visits.
Best-corrected visual acuity will also be measured for each distance (distance, intermediate, and near).
Defocus Curve:
A series of measurements at different distances will assess the functional range of vision provided by the PureSee™ IOL.
Contrast Sensitivity:
Measured under controlled conditions to evaluate patients' ability to distinguish objects in low-contrast or low-light environments.
Study Duration
Study Enrollment Period: Patients will be recruited over a defined period, with enrollment based on their scheduled triple DMEK surgery.
Follow-up Period: Participants will be followed for six months post-surgery.
Study Significance
The results of this study will provide valuable data on the visual outcomes of patients undergoing triple DMEK surgery with the implantation of the PureSee™ IOL. This new lens may offer significant advantages in terms of visual quality, particularly for intermediate vision, which is often a challenge after traditional IOL implantation in DMEK. This study will help guide IOL selection strategies and improve postoperative care for patients undergoing complex cataract and corneal surgery.
The findings may also contribute to expanding the available options for patients with cataracts and endothelial dysfunction undergoing DMEK, offering the potential for better outcomes and increased spectacle independence.
- Conditions
- Cataract, Fuchs Endothelial Corneal Dystrophy
- Being tested
- combined cataract and lamellar endothelial keratoplasty
- Keywords
- dmek, triple, endothelial keratoplasty, fuchs, cataract, edof iol, partial range of field iol
- Medical subject headings
- Cataract, Fuchs' Endothelial Dystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined cataract and lamellar endothelial keratoplastyDevice
PureSee™ IOL in combined cataract and lamellar endothelial keratoplasty
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Not described Receives: Device: combined cataract and lamellar endothelial keratoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncorrected intermediate visual acuity on Radner reading chart in LogMAR (logarithm of minimum angle of resolution) scale (range -0.3 till 3),
To evaluate the uncorrected intermediate visual acuity (UIVA) achieved through PureSee™ IOL (extended PRoF IOL) implantation in triple DMEK surgery at 66cm on Radner reading chart in photopic conditions and 100% contrast measured in LogMAR scale (range -0.3 till 3). Lower score indicates better outcome.
Measured: From enrollment to 6 months post surgery
Secondary outcomes (3)
Patient reported spectacle independence measured with PRSIQ questionaire (patient reported spectacle independence questionaire) and PRVSQ (patient reported visual symptom questionaire) both in Likert scale with component scores from 1 till 6
To assess patient reported spectacle independence in DMEK + extended ProF IOL patients. Lower score indicates better outcome.
Measured: From enrollment till 6 months post surgery
monocular uncorrected and best corrected distance, intermediate and near visual acuity as well as the uncorrected defocus curve in photopic conditions and 100% contrast measured in LogMAR scale (range -0.3 till 3) at 4m, 66cm and 40cm on EDTRS and Radner
To assess monocular uncorrected and best corrected distance, intermediate and near visual acuity as well as the uncorrected defocus curve in DMEK + extended ProF IOL patients. Lower score indicates better outcome.
Measured: From enrollment till 6 months post surgery
contrast sensitivity in photopic conditions without glare and mesopic conditions with and without glare with Clinical CSF V.2.0.1, (QVision Academy, Spain) in log10 units, Modulation tranfer function cut-off
To assess contrast sensitivity in DMEK + extended Prof IOL patients. Higher score indicates better result.
Measured: From enrollment till 6 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study startOct 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (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 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Sponsor
- Investigators
- Karolien Termote, MF, Febo, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07441616
- Sponsor's protocol ID
- 25343_Profide
- Acronym
- PROFIDE
- Status last verified
- Aug 2026
- First submitted
- 26 Jan 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mencucci R, Romualdi G, De Vitto C, Cennamo M. Enhanced Monofocal Intraocular Lenses in Fuchs' Endothelial Dystrophy Patients: Results from Triple Descemet Membrane Endothelial Keratoplasty Procedure. Life (Basel). 2024 Feb 9;14(2):243. doi: 10.3390/life14020243.
PubMed 38398752
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study Evaluating Visual Outcomes of Extended Partial Range of Field Refractive Intraocular Lenses in Patients Undergoing Combined Cataract Surgery and Descemet Membrane Endothelial Keratoplasty (Triple DMEK)
- ClinicalTrials.gov ID
- NCT07441616
- Acronym / sponsor ID
- PROFIDE / 25343_Profide
- Conditions
- Cataract, Fuchs Endothelial Corneal Dystrophy
- Keywords
- dmek, triple, endothelial keratoplasty, fuchs, cataract, edof iol, partial range of field iol
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Study start
- Oct 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 2 Mar 2026 (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.
Study Overview
This study aims to evaluate the visual outcomes, quality of vision, and patient satisfaction after receiving an extended range PRoF intraocular lens (IOL) during triple Descemet Membrane Endothelial Keratoplasty (DMEK) surgery. This surgery is typically performed to treat patients with both corneal endothelial dysfunction and cataracts. By testing a newer IOL, the PureSee™ extended PRoF IOL, this study hopes to improve the way ophthalmologists plan surgeries and select IOLs for these patients, ultimately helping surgeons optimize the results and expand the options available for people undergoing this procedure.
Purpose of the Study
The goal of this study is to evaluate how well the PureSee™ IOL works in terms of intermediate visual acuity (how well participants can see things at an arm's length). The investigators will also measure the quality of vision, satisfaction, and whether participants need glasses after surgery.
The investigators have set the following goals for this study:
Primary Goal:
To measure how well patients can see intermediate distances (uncorrected intermediate visual acuity, or UIVA) after receiving the PureSee™ IOL during triple DMEK surgery.
Secondary Goals:
To understand how independent patients are from glasses after surgery.
To measure patients' uncorrected and best-corrected visual acuity (sharpness of vision) at distance, intermediate, and near vision after surgery.
To evaluate the uncorrected defocus curve (how the vision of participants changes when focusing at different distances).
To measure contrast sensitivity (how well participants can see in low-light conditions or with subtle contrasts).
Who Can Join This Study?
To participate in this study, participants need to:
Be undergoing triple DMEK surgery for endothelial dysfunction and cataract at the time of enrollment.
Be eligible to receive an extended range of vision IOL as part of the procedure.
This study is looking for patients who are interested in understanding how new IOL technology might improve their postoperative vision quality and reduce their dependence on glasses.
What Will Happen During the Study?
Participants will have their visual outcomes and satisfaction measured at specific times following surgery. This includes:
Testing uncorrected and best-corrected visual acuity at several distances (distance, intermediate, and near).
Completing a survey about how satisfied they are with their vision and how often they need glasses or contact lenses.
Undergoing testing to measure contrast sensitivity (how well participants can see in low-light conditions).
Why Is This Study Important?
The results of this study will help doctors make better decisions about which IOLs to use during triple DMEK surgery. By evaluating the PureSee™ extended PRoF IOL, the investigators hope to expand options for patients and potentially improve visual outcomes and postoperative satisfaction. Ultimately, this study could help improve the quality of life for patients who have both cataracts and endothelial dysfunction.
Study Duration
Participants can expect to undergo their last assessment 6 months post-surgery to track their progress.
Detailed description
Detailed Study Description
This feasibility study is designed to evaluate the visual acuity, quality of vision, refractive outcomes, and patient satisfaction following the implantation of an extended range PRoF intraocular lens (IOL), specifically the PureSee™ IOL, during triple Descemet Membrane Endothelial Keratoplasty (DMEK) surgery. Triple DMEK is a combined procedure for patients with both corneal endothelial dysfunction and cataracts. The main goal of this study is to explore whether the PureSee™ IOL can improve visual outcomes and help reduce the need for glasses, ultimately improving the postoperative experience for these patients.
This study aims to provide valuable data on IOL selection and surgical planning for triple DMEK procedures. The findings will help expand the options available to patients and optimize their visual outcomes after surgery.
Study Objectives
The main objective of this study is to evaluate the visual outcomes, patient satisfaction, and overall success of PureSee™ IOL implantation in a clinical triple DMEK setting. The study will focus on the following specific goals:
Primary Objective
Uncorrected Intermediate Visual Acuity (UIVA):
To evaluate the uncorrected intermediate visual acuity (UIVA) achieved by the PureSee™ IOL in patients undergoing triple DMEK surgery. UIVA will be measured as the primary outcome.
Secondary Objectives
Spectacle Independence:
To assess patient-reported spectacle independence, meaning how often patients can go without glasses or contact lenses following triple DMEK surgery with PureSee™ IOL implantation.
Monocular Visual Acuity:
To measure monocular uncorrected and best-corrected distance, intermediate, and near visual acuity after surgery. This will help determine how well patients can see at various distances (far, near, and intermediate) both without correction (uncorrected) and with glasses or contact lenses (best corrected).
Defocus Curve:
To assess the uncorrected defocus curve, which measures how vision changes as patients focus on objects at different distances, from near to far. This curve helps characterize the range of vision patients experience with the IOL.
Contrast Sensitivity:
To evaluate contrast sensitivity, which tests the ability to see in low-light conditions or perceive subtle contrasts between objects, an important aspect of functional vision for everyday activities such as driving at night or reading.
Study Population
The study will include patients undergoing triple DMEK surgery for the treatment of both endothelial dysfunction and cataracts. Participants will be eligible to receive an extended range PRoF IOL, and must meet the inclusion criteria for the procedure. Specifically, the following criteria will apply:
Patients must be scheduled for triple DMEK surgery.
Patients must be willing to participate in the study and attend follow-up visits.
Study Design
This is a prospective, observational study. All patients will undergo triple DMEK surgery as part of routine clinical care, with the PureSee™ IOL being implanted during the procedure. The study will monitor patients' visual outcomes over several months following surgery.
Interventions
Intervention Group: Patients undergoing triple DMEK surgery will receive the PureSee™ IOL (extended range PRoF IOL).
Outcome Measures
The following primary and secondary outcome measures will be used to evaluate the effectiveness and impact of the PureSee™ IOL:
Primary Outcome
Uncorrected Intermediate Visual Acuity (UIVA): This will be measured at a defined postoperative time point.
Secondary Outcomes
Spectacle Independence: Assessed by patient-reported questionnaires regarding their use of glasses or contact lenses after surgery.
Monocular Visual Acuity:
Uncorrected distance, intermediate, and near visual acuity will be measured for both eyes at multiple postoperative visits.
Best-corrected visual acuity will also be measured for each distance (distance, intermediate, and near).
Defocus Curve:
A series of measurements at different distances will assess the functional range of vision provided by the PureSee™ IOL.
Contrast Sensitivity:
Measured under controlled conditions to evaluate patients' ability to distinguish objects in low-contrast or low-light environments.
Study Duration
Study Enrollment Period: Patients will be recruited over a defined period, with enrollment based on their scheduled triple DMEK surgery.
Follow-up Period: Participants will be followed for six months post-surgery.
Study Significance
The results of this study will provide valuable data on the visual outcomes of patients undergoing triple DMEK surgery with the implantation of the PureSee™ IOL. This new lens may offer significant advantages in terms of visual quality, particularly for intermediate vision, which is often a challenge after traditional IOL implantation in DMEK. This study will help guide IOL selection strategies and improve postoperative care for patients undergoing complex cataract and corneal surgery.
The findings may also contribute to expanding the available options for patients with cataracts and endothelial dysfunction undergoing DMEK, offering the potential for better outcomes and increased spectacle independence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Device: combined cataract and lamellar endothelial keratoplasty |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with bilateral cataract grade greater than II, according to the Lens Opacities Classification System III (LOCS III) , combined with FECD displaying clinical or subclinical corneal edema or displaying visual disturbing guttae with at least Krachmer grade 3
- Patients aged between 40 and 90 years
- Capacity to read and to understand the study information and to provide informed consent, as well as Patient Reported Spectacle Independence Questionnaire (PRSIQ) and Patient Reported Visual Symptom Questionnaire (PRVSQ)
- Patients willing and capable to attend the 6-month follow-up appointment
Key exclusion criteria (13 listed)
- history of ocular surgery
- corneal scars
- macular disease revealed by pre-surgical macular Optical Coherence Tomography (OCT),
- opticopathy
- glaucoma with reduced sensitivity of visual field
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 |
|---|---|---|
| combined cataract and lamellar endothelial keratoplastyPureSee™ IOL in combined cataract and lamellar endothelial keratoplasty | Device | Single arm |
Primary outcome
Uncorrected intermediate visual acuity on Radner reading chart in LogMAR (logarithm of minimum angle of resolution) scale (range -0.3 till 3),
Time frame: From enrollment to 6 months post surgery
To evaluate the uncorrected intermediate visual acuity (UIVA) achieved through PureSee™ IOL (extended PRoF IOL) implantation in triple DMEK surgery at 66cm on Radner reading chart in photopic conditions and 100% contrast measured in LogMAR scale (range -0.3 till 3). Lower score indicates better outcome.
3 secondary outcomes
Patient reported spectacle independence measured with PRSIQ questionaire (patient reported spectacle independence questionaire) and PRVSQ (patient reported visual symptom questionaire) both in Likert scale with component scores from 1 till 6
Time frame: From enrollment till 6 months post surgery
monocular uncorrected and best corrected distance, intermediate and near visual acuity as well as the uncorrected defocus curve in photopic conditions and 100% contrast measured in LogMAR scale (range -0.3 till 3) at 4m, 66cm and 40cm on EDTRS and Radner
Time frame: From enrollment till 6 months post surgery
contrast sensitivity in photopic conditions without glare and mesopic conditions with and without glare with Clinical CSF V.2.0.1, (QVision Academy, Spain) in log10 units, Modulation tranfer function cut-off
Time frame: From enrollment till 6 months post surgery
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 25 Aug 2026.
- Background: PubMed 38398752Mencucci R, Romualdi G, De Vitto C, Cennamo M. Enhanced Monofocal Intraocular Lenses in Fuchs' Endothelial Dystrophy Patients: Results from Triple Descemet Membrane Endothelial Keratoplasty Procedure. Life (Basel). 2024 Feb 9;14(2):243. doi: 10.3390/life14020243.
- Individual participant dataSharing planned: Undecided
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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.
Karolien Termote, MF, Febo principal investigator
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combined cataract and lamellar endothelial keratoplasty in people with Cataract and Fuchs Endothelial Corneal Dystrophy, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 13 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: opening soon, as of the sponsor's last update on 25 Aug 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 Belgium. 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 Karolien Termote, MD, Febo (+32475878777, karolien.termote@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uncorrected intermediate visual acuity on Radner reading chart in LogMAR (logarithm of minimum angle of resolution) scale (range -0.3 till 3), (time frame: From enrollment to 6 months post 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 NCT07441616, 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 25 Aug 2026.