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

Primary Purpose

Fuch's Endothelial Dystrophy, Cataracts

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Spheric Sensar(R) 3-piece IOL
Aspheric Tecnis(R) 3-piece IOL
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fuch's Endothelial Dystrophy focused on measuring Fuch's endothelial dystrophy, Aspheric intraocular lens, Higher Order Aberrations, Contrast Sensitivity

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hotel Dieu Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Spheric Sensar(R) 3-piece IOL

Aspheric Tecnis(R) 3-piece IOL

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in contrast sensitivity.

Secondary Outcome Measures

Higher Order Aberrations

Full Information

First Posted
April 7, 2014
Last Updated
September 26, 2016
Sponsor
Queen's University
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1. Study Identification

Unique Protocol Identification Number
NCT02109276
Brief Title
Study of the Effect of Aspheric Lenses in Patients With Fuch's Dystrophy
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Withdrawn
Why Stopped
not enough participants
Study Start Date
April 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fuch's Endothelial Dystrophy, Cataracts
Keywords
Fuch's endothelial dystrophy, Aspheric intraocular lens, Higher Order Aberrations, Contrast Sensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spheric Sensar(R) 3-piece IOL
Arm Type
Active Comparator
Arm Description
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
Arm Title
Aspheric Tecnis(R) 3-piece IOL
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Spheric Sensar(R) 3-piece IOL
Intervention Description
Patients will be randomized to receive either a standard spheric intraocular lens or an aspheric intraocular lens
Intervention Type
Device
Intervention Name(s)
Aspheric Tecnis(R) 3-piece IOL
Intervention Description
Patients will be randomized to receive either a standard spheric intraocular lens or an aspheric intraocular lens
Primary Outcome Measure Information:
Title
Change in contrast sensitivity.
Time Frame
3 months (plus or minus 1 week) post operatively
Secondary Outcome Measure Information:
Title
Higher Order Aberrations
Time Frame
3 months (plus or minus 1 week) post operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Baxter, MD, FRCSC
Organizational Affiliation
Department of Ophthalmology, Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hotel Dieu Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5G2
Country
Canada

12. IPD Sharing Statement

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

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