Fuch's Endothelial DystrophyNCT02109276
Study of the Effect of Aspheric Lenses in Patients With Fuch's Dystrophy
A study testing Spheric Sensar(R) 3-piece IOL and Aspheric Tecnis(R) 3-piece IOL in people with Fuch's Endothelial Dystrophy and Cataracts, run by Queen's University at 1 site in Canada.
Trial summary
The proposed study will recruit patients with mild to moderate Fuch's dystrophy who need cataract surgery alone. They will be randomly assigned to receive either spheric or aspheric lenses. If both eyes of a patient need surgery, we will implant the same type of lens in each eye in order to prevent imbalanced vision. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fuch's Endothelial Dystrophy, Cataracts
- What is being tested?
- Spheric Sensar(R) 3-piece IOL and Aspheric Tecnis(R) 3-piece IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2014to Jun 2016
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 and 80 years
- Visual acuity better than 0.2 logMAR units
- preoperative corneal spherical aberration (Zo4) values between 0.1 and 0.25 µm at 5-mm pupil diameter
- IOL power between +18.00 and +24.00 diopters
Who cannot join
- Intraocular lens tilt and decentration estimated by retroillumination
- surgical complications
- posterior capsule rupture
- residual posterior capsule plaque
- posterior capsular opacity
- post operative Best Corrected Visual Acuity <20/25
Show all 20Show fewer
- corneal astigmatism >= 1.00 D
- glaucoma
- amblyopia,
- history of uveitis
- diabetic retinopathy,
- pseudoexfoliation syndrome
- macular pathology previous intraocular surgery
- coexisting ocular pathology
- axial length >25mm
- non dilating pupils
- corneal laser therapy
- poor follow up
- use of topical medications (apart from lubricants)
- systemic steroids use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contrast Sensitivity and Higher Order Aberrations After Spheric and Aspheric Intraocular Lens Implantation for Patients With Mild to Moderate Fuch's Endothelial Dystrophy.
The proposed study will recruit patients with mild to moderate Fuch's dystrophy who need cataract surgery alone. They will be randomly assigned to receive either spheric or aspheric lenses. If both eyes of a patient need surgery, we will implant the same type of lens in each eye in order to prevent imbalanced vision. We will measure their contrast sensitivity and higher order aberrations before surgery and 3 months after surgery. We will compare the change in these values between the two groups.
Read the detailed description
Fuch's endothelial dystrophy is a disease of the human cornea, which affects people in the fifth or sixth decade of life. Due to poorly functioning cells its inner surface, the cornea becomes swollen, resulting in pain and blurry vision. Mild to moderate Fuch's disease can be managed pharmacologically or conservatively. Nonetheless, cataract development is an unrelated age-associated process that occurs in the same way in patients with and without Fuch's endothelial dystrophy. Therefore, many patients with mild to moderate Fuch's dystrophy would need to undergo cataract surgery.
In cataract surgery, the native human lens is removed and replaced with a synthetic intraocular lens. There are several varieties of lenses available currently. Of these, the aspheric lens has a unique contour that was developed to complement the surface features of the cornea, thus reducing spherical aberrations. Several studies have shown that the aspheric lens improves contrast sensitivity in dim light and higher order aberrations in the otherwise normal eye. Contrast sensitivity refers to the ability of the patient to discern differences in similar shades of colour. Higher order aberration is a concept that is used to quantify how much the optical mechanism of the eye distorts incoming light rays. Most of these studies compared the aspheric lens to the standard spheric lens.
Since Fuch's patients can experience intermittent corneal swelling, the shape of their corneal surface is prone to distortion. Since the aspheric lens does not change shape, it is unknown how its fixed surface will interact with the fluctuating corneal surface in patients with Fuch's endothelial dystrophy.
To date, there have been no studies looking at contrast sensitivity and higher order aberrations in patients with Fuch's dystrophy who were implanted with an aspheric intraocular lens. The accepted practice is to offer Fuch's patients the aspheric lens during the pre-operative evaluation, and explain to them that we are not sure how it will be of benefit to them. At Hotel Dieu Hospital in Kingston, there is a cost of $125 to all patients who choose the aspheric lens, while the spheric lens is free. Therefore, most patients with Fuch's dystrophy choose the spheric lens. There is no evidence-based data to guide patient choice in this situation.
- Conditions
- Fuch's Endothelial Dystrophy, Cataracts
- Being tested
- Spheric Sensar(R) 3-piece IOL, Aspheric Tecnis(R) 3-piece IOL
- Keywords
- Fuch's endothelial dystrophy, Aspheric intraocular lens, Higher Order Aberrations, Contrast Sensitivity
- Medical subject headings
- Fuchs' Endothelial Dystrophy, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spheric Sensar(R) 3-piece IOLDevice
Patients will be randomized to receive either a standard spheric intraocular lens or an aspheric intraocular lens
Aspheric Tecnis(R) 3-piece IOLDevice
Patients will be randomized to receive either a standard spheric intraocular lens or an aspheric intraocular lens
| Study group | Role | What they receive |
|---|---|---|
| Spheric Sensar(R) 3-piece IOL | Active comparator | This group of patients with Fuchs endothelial dystrophy and cataract will undergo cataract extraction and be randomized to receive a Spheric Sensar(R) 3-piece IOL Receives: Device: Spheric Sensar(R) 3-piece IOL |
| Aspheric Tecnis(R) 3-piece IOL | Experimental | This group of patients with Fuchs endothelial dystrophy and cataract will undergo cataract extraction and be randomized to receive an Aspheric Tecnis(R) 3-piece IOL Receives: Device: Aspheric Tecnis(R) 3-piece IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in contrast sensitivity.
Measured: 3 months (plus or minus 1 week) post operatively
Secondary outcomes (1)
Higher Order Aberrations
Measured: 3 months (plus or minus 1 week) post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: not enough participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fuch's Endothelial 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Stephanie Baxter, Queen's University
- Investigators
- Stephanie Baxter, MD, FRCSC, Principal investigator, Department of Ophthalmology, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02109276
- Sponsor's protocol ID
- OPTH-151-14
- Status last verified
- Sep 2016
- First submitted
- 7 Apr 2014
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast Sensitivity and Higher Order Aberrations After Spheric and Aspheric Intraocular Lens Implantation for Patients With Mild to Moderate Fuch's Endothelial Dystrophy.
- ClinicalTrials.gov ID
- NCT02109276
- Acronym / sponsor ID
- OPTH-151-14
- Conditions
- Fuch's Endothelial Dystrophy, Cataracts
- Keywords
- Fuch's endothelial dystrophy, Aspheric intraocular lens, Higher Order Aberrations, Contrast Sensitivity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: not enough participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 9 Apr 2014 (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.
The proposed study will recruit patients with mild to moderate Fuch's dystrophy who need cataract surgery alone. They will be randomly assigned to receive either spheric or aspheric lenses. If both eyes of a patient need surgery, we will implant the same type of lens in each eye in order to prevent imbalanced vision. We will measure their contrast sensitivity and higher order aberrations before surgery and 3 months after surgery. We will compare the change in these values between the two groups.
Detailed description
Fuch's endothelial dystrophy is a disease of the human cornea, which affects people in the fifth or sixth decade of life. Due to poorly functioning cells its inner surface, the cornea becomes swollen, resulting in pain and blurry vision. Mild to moderate Fuch's disease can be managed pharmacologically or conservatively. Nonetheless, cataract development is an unrelated age-associated process that occurs in the same way in patients with and without Fuch's endothelial dystrophy. Therefore, many patients with mild to moderate Fuch's dystrophy would need to undergo cataract surgery.
In cataract surgery, the native human lens is removed and replaced with a synthetic intraocular lens. There are several varieties of lenses available currently. Of these, the aspheric lens has a unique contour that was developed to complement the surface features of the cornea, thus reducing spherical aberrations. Several studies have shown that the aspheric lens improves contrast sensitivity in dim light and higher order aberrations in the otherwise normal eye. Contrast sensitivity refers to the ability of the patient to discern differences in similar shades of colour. Higher order aberration is a concept that is used to quantify how much the optical mechanism of the eye distorts incoming light rays. Most of these studies compared the aspheric lens to the standard spheric lens.
Since Fuch's patients can experience intermittent corneal swelling, the shape of their corneal surface is prone to distortion. Since the aspheric lens does not change shape, it is unknown how its fixed surface will interact with the fluctuating corneal surface in patients with Fuch's endothelial dystrophy.
To date, there have been no studies looking at contrast sensitivity and higher order aberrations in patients with Fuch's dystrophy who were implanted with an aspheric intraocular lens. The accepted practice is to offer Fuch's patients the aspheric lens during the pre-operative evaluation, and explain to them that we are not sure how it will be of benefit to them. At Hotel Dieu Hospital in Kingston, there is a cost of $125 to all patients who choose the aspheric lens, while the spheric lens is free. Therefore, most patients with Fuch's dystrophy choose the spheric lens. There is no evidence-based data to guide patient choice in this situation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spheric Sensar(R) 3-piece IOL | Active comparator | Device: Spheric Sensar(R) 3-piece IOLThis group of patients with Fuchs endothelial dystrophy and cataract will undergo cataract extraction and be randomized to receive a Spheric Sensar(R) 3-piece IOL |
| Aspheric Tecnis(R) 3-piece IOL | Experimental | Device: Aspheric Tecnis(R) 3-piece IOLThis group of patients with Fuchs endothelial dystrophy and cataract will undergo cataract extraction and be randomized to receive an Aspheric Tecnis(R) 3-piece IOL |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 and 80 years
- Visual acuity better than 0.2 logMAR units
- preoperative corneal spherical aberration (Zo4) values between 0.1 and 0.25 µm at 5-mm pupil diameter
- IOL power between +18.00 and +24.00 diopters
Key exclusion criteria (20 listed)
- Intraocular lens tilt and decentration estimated by retroillumination
- surgical complications
- posterior capsule rupture
- residual posterior capsule plaque
- posterior capsular opacity
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 |
|---|---|---|
| Spheric Sensar(R) 3-piece IOLPatients will be randomized to receive either a standard spheric intraocular lens or an aspheric intraocular lens | Device | Spheric Sensar(R) 3-piece IOL |
| Aspheric Tecnis(R) 3-piece IOLPatients will be randomized to receive either a standard spheric intraocular lens or an aspheric intraocular lens | Device | Aspheric Tecnis(R) 3-piece IOL |
Primary outcome
Change in contrast sensitivity.
Time frame: 3 months (plus or minus 1 week) post operatively
1 secondary outcome
Higher Order Aberrations
Time frame: 3 months (plus or minus 1 week) post operatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
Related trials for Fuch's Endothelial Dystrophy
Active, not recruitingPhase 3
Descemet Endothelial Thickness Comparison Trial II
Fuchs, Fuchs Dystrophy
RecruitingPhase 2
Study of EO2002 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction
Corneal Edema, Fuchs
RecruitingObservational study
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
Keratoconus, Ectasia
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
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.
Stephanie Baxter, MD, FRCSC principal investigator
Department of Ophthalmology, Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spheric Sensar(R) 3-piece IOL and Aspheric Tecnis(R) 3-piece IOL in people with Fuch's Endothelial Dystrophy and Cataracts, run by Queen's University at 1 site in Canada.
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 20 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: withdrawn, as of the sponsor's last update on 27 Sep 2016. 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 Canada. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in contrast sensitivity. (time frame: 3 months (plus or minus 1 week) post operatively). 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 27 Sep 2016.