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

September 26, 2016 updated by: Dr. Stephanie Baxter, Queen's University

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 5G2
        • Hotel Dieu Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in contrast sensitivity.
Time Frame: 3 months (plus or minus 1 week) post operatively
3 months (plus or minus 1 week) post operatively

Secondary Outcome Measures

Outcome Measure
Time Frame
Higher Order Aberrations
Time Frame: 3 months (plus or minus 1 week) post operatively
3 months (plus or minus 1 week) post operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen's University

Investigators

  • Principal Investigator: Stephanie Baxter, MD, FRCSC, Department of Ophthalmology, Queen's University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

April 7, 2014

First Submitted That Met QC Criteria

April 8, 2014

First Posted (ESTIMATE)

April 9, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

September 27, 2016

Last Update Submitted That Met QC Criteria

September 26, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPTH-151-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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