Trial record 1 of 20 for:    "Fuchs endothelial dystrophy" OR "Corneal Granular Dystrophies" OR "Hereditary Corneal Dystrophies" OR "Corneal Macular Dystrophy"
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Study of the Effect of Aspheric Lenses in Patients With Fuch's Dystrophy

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by Queen's University
Sponsor:
Information provided by (Responsible Party):
Queen's University
ClinicalTrials.gov Identifier:
NCT02109276
First received: April 7, 2014
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Fuch's Endothelial Dystrophy
Cataracts
Procedure: Surgery for cataract extraction
Device: Aspheric Tecnis(R) 3-piece intraocular lens placement
Device: Spheric AR40e intraocular lens placement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Change in contrast sensitivity. [ Time Frame: 3 months (plus or minus 1 week) post operatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Higher Order Aberrations [ Time Frame: 3 months (plus or minus 1 week) post operatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: April 2014
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Spheric intraocular lens
Surgery for cataract extraction and 3-piece AR40e intraocular lens placement.
Procedure: Surgery for cataract extraction Device: Spheric AR40e intraocular lens placement
Other Name: AR40e manufactured by Abbott Medical Ophthalmics
Experimental: Aspheric Intraocular Lens
Surgery for cataract extraction and Technis® 3-piece intraocular lens placement
Procedure: Surgery for cataract extraction Device: Aspheric Tecnis(R) 3-piece intraocular lens placement
Other Name: Tecnis(R) 3-piece intraocular lens manufactured by Abbott Medical Ophthalmics

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • corneal astigmatism >= 1.00 D
  • glaucoma
  • amblyopi,
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02109276

Contacts
Contact: Stephanie Baxter, MD, FRCSC 613 544 3400 ext 3203 sbaxter@baxtereyemd.com
Contact: Amaka A Eneh, MD 613 929 5732 amaka_eneh@yahoo.ca

Locations
Canada, Ontario
Hotel Dieu Hospital Not yet recruiting
Kingston, Ontario, Canada, K7L 5G2
Sponsors and Collaborators
Queen's University
Investigators
Principal Investigator: Stephanie Baxter, MD, FRCSC Department of Ophthalmology, Queen's University
  More Information

No publications provided

Responsible Party: Queen's University
ClinicalTrials.gov Identifier: NCT02109276     History of Changes
Other Study ID Numbers: OPTH-151-14
Study First Received: April 7, 2014
Last Updated: April 8, 2014
Health Authority: Canada: Health Canada

Keywords provided by Queen's University:
Fuch's endothelial dystrophy
Aspheric intraocular lens
Higher Order Aberrations
Contrast Sensitivity

Additional relevant MeSH terms:
Fuchs' Endothelial Dystrophy
Corneal Dystrophies, Hereditary
Corneal Diseases
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on October 16, 2014