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)
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Uncorrected intermediate visual acuity on Radner reading chart in LogMAR (logarithm of minimum angle of resolution) scale (range -0.3 till 3),
Overview
Brief 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. 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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
- •amblyopia
- •axial length \<22mm or \>25mm,
- •scotopic pupil size \>5mm,
- •central corneal thickness \>700microns,
- •corneal astigmatism \>1 diopters (D) on biometry
Arms & Interventions
Single arm
Intervention: combined cataract and lamellar endothelial keratoplasty (Device)
Outcomes
Primary Outcomes
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.
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(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(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(From enrollment till 6 months post surgery)