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

NCT02109276 | Withdrawn

• 1 other identifier: OPTH-151-14
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Fuch's Endothelial Dystrophy; Cataracts

Keywords

Fuch's endothelial dystrophy; Aspheric intraocular lens; Higher Order Aberrations; Contrast Sensitivity

Outcome Measures

Primary Outcomes (1)

• Change in contrast sensitivity.

  3 months (plus or minus 1 week) post operatively

Secondary Outcomes (1)

• Higher Order Aberrations

  3 months (plus or minus 1 week) post operatively

Study Arms (2)

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

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

Device: Aspheric Tecnis(R) 3-piece IOL

Interventions

Spheric Sensar(R) 3-piece IOL DEVICE

Patients will be randomized to receive either a standard spheric intraocular lens or an aspheric intraocular lens

Spheric Sensar(R) 3-piece IOL

Aspheric Tecnis(R) 3-piece IOL DEVICE

Patients will be randomized to receive either a standard spheric intraocular lens or an aspheric intraocular lens

Aspheric Tecnis(R) 3-piece IOL

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Hotel Dieu Hospital

Kingston, Ontario, K7L 5G2, Canada

Location

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy; Cataract

Condition Hierarchy (Ancestors)

Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lens Diseases

Study Officials

• Stephanie Baxter, MD, FRCSC

  Department of Ophthalmology, Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 7, 2014
• First Posted: April 9, 2014
• Study Start: April 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: September 27, 2016

Record last verified: 2016-09

Locations

CA (1)