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Study of the Effect of Aspheric Lenses in Patients With Fuch's Dystrophy

This study has been withdrawn prior to enrollment.
(not enough participants)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02109276
First Posted: April 9, 2014
Last Update Posted: September 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Stephanie Baxter, Queen's University
  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 Device: Spheric Sensar(R) 3-piece IOL Device: Aspheric Tecnis(R) 3-piece IOL

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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 Dr. Stephanie Baxter, Queen's University:

Primary Outcome Measures:
  • Change in contrast sensitivity. [ Time Frame: 3 months (plus or minus 1 week) post operatively ]

Secondary Outcome Measures:
  • Higher Order Aberrations [ Time Frame: 3 months (plus or minus 1 week) post operatively ]

Enrollment: 0
Study Start Date: April 2014
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Spheric Sensar(R) 3-piece IOL
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
Device: Spheric Sensar(R) 3-piece IOL
Patients will be randomized to receive either a standard spheric intraocular lens or an aspheric intraocular lens
Experimental: Aspheric Tecnis(R) 3-piece IOL
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
Device: Aspheric Tecnis(R) 3-piece IOL
Patients will be randomized to receive either a standard spheric intraocular lens or an aspheric intraocular lens

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02109276


Locations
Canada, Ontario
Hotel Dieu Hospital
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

Responsible Party: Dr. Stephanie Baxter, Principal Investigator, Queen's University
ClinicalTrials.gov Identifier: NCT02109276     History of Changes
Other Study ID Numbers: OPTH-151-14
First Submitted: April 7, 2014
First Posted: April 9, 2014
Last Update Posted: September 27, 2016
Last Verified: September 2016

Keywords provided by Dr. Stephanie Baxter, Queen's University:
Fuch's endothelial dystrophy
Aspheric intraocular lens
Higher Order Aberrations
Contrast Sensitivity

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