Assessment of Visual Function and Optics in Intraocular Lenses

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2013 by Aston University
Sponsor:
Information provided by (Responsible Party):
Aston University
ClinicalTrials.gov Identifier:
NCT01654159
First received: July 17, 2012
Last updated: July 15, 2013
Last verified: July 2013
  Purpose

The main objective of this research is to assess visual function and optical performance of CE marked, implanted intraocular lenses to understand the individual factors that affect their performance and how these may be improved in future designs and to evaluate measurement techniques.

All outcome measures will be captured 3-6 months after surgery


Condition Intervention Phase
Cataract
Procedure: Monofocal IOL
Procedure: Multifocal IOL
Procedure: Toric IOL
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Evaluating Subjective and Objective Performance of Instrumentation Used and Devices Implanted in Cataract Surgery

Resource links provided by NLM:


Further study details as provided by Aston University:

Primary Outcome Measures:
  • Unaided distance and near vision [ Time Frame: Measured at 3-6 months after surgery ] [ Designated as safety issue: No ]
    Visual Acuity (logMAR)


Secondary Outcome Measures:
  • Patient Satisfaction [ Time Frame: Measured at 3-6 months after surgery ] [ Designated as safety issue: No ]
    NAVQ score

  • Residual refraction [ Time Frame: Measured at 3-6 months after surgery ] [ Designated as safety issue: No ]
    Autorefraction / subjective refraction

  • Aberrations [ Time Frame: Measured at 3-6 months after surgery ] [ Designated as safety issue: No ]
    Aberrometry

  • Corrected distance and near acuity [ Time Frame: Measured at 3-6 months after surgery ] [ Designated as safety issue: No ]
    Acuity (logMAR)


Estimated Enrollment: 500
Study Start Date: September 2013
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Monofocal

Monofocal IOL Implant

Manufacturers of IOLs used as monofocal comparator are Alcon, AMO, Bausch and Lomb, Lenstec, Oculentis, Ophthec, Physiol and Zeiss

Procedure: Monofocal IOL
Monofocal Intraocular lens will be implanted
Other Name: Alcon AMO B&L Lenstec Oculentis Ophthec Physiol & Zeiss
Experimental: Multifocal

Multifocal IOL

Manufacturers of multifocal IOLs under investigation are Alcon, AMO, Bausch and Lomb, Lenstec, Oculentis, Ophthec, Physiol and Zeiss

Procedure: Multifocal IOL
Multifocal IOL will be implanted
Experimental: Toric

Toric IOL

Manufacturers of toric IOLs under investigation are Alcon, AMO, Bausch and Lomb, Lenstec, Oculentis, Ophthec, Physiol and Zeiss

Procedure: Toric IOL
Toric IOLS will be implanted

Detailed Description:

A cataract occurs when the natural lens of the eye, which plays a major role in the focusing of light and production of sharp visual images, becomes cloudy and hardens, resulting in a loss of visual function. Left untreated, cataracts can cause preventable blindness. During cataract surgery the natural lens is removed and a man-made intraocular lens (IOL) is implanted in its place.

IOL technology has advanced significantly in recent years and as a result the main goal of cataract surgery is no longer simply the successful removal of the cloudy lens and restoration of vision. Providing patients with the best possible refractive outcome and the best possible visual quality is now much more important when assessing surgery outcomes.

Aspheric, multifocal and accommodating IOLs are among the new designs developed to improve visual outcome after cataract surgery. In order to assess the effectiveness of these designs, visual function needs to be evaluated both objectively and subjectively following their implantation. Such evaluation allows the continued evolution of these IOL designs towards optimum. This proposed research study, which aims to assess the visual function and optical performance of new CE marked IOLs after implantation, could significantly contribute to the enhancement and development of improved IOL designs in the future.

We have successfully conducted similar patient trials for the past 5 years. As new IOL designs are constantly being developed, approved and CE marked, this type of research study will always have the potential to offer new information that is not currently available and has not previously been assessed or published and could contribute towards improved IOL designs in the future.

All outcome measures will be captured 3-6 months after surgery

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects age between 40-85 years, may be either male or female, and may be of any race (as cataracts rarely occur before the age of 40 and above 85 other ocular pathology is common).
  • Subjects requiring cataract surgery.
  • Potential for best corrected visual acuity of 6/12 or better (as visual function in these patients will be affected by ocular pathology).
  • Subjects with clear intraocular media other than cataract (as assessing cataract).
  • General physical and mental condition allowing participation in current study.
  • Subjects willing to participate as evidenced by signing the written informed

Exclusion Criteria:

  • Prior surgery on the selected eye
  • Previous uveitis or trauma to the selected eye, anterior or posterior synechiae
  • Potential for best corrected visual acuity worse than 6/12 (since this may indicate other causes of ocular pathology)
  • Partial or total paralysis, Parkinsons syndrome, cerebrovascular accident or other condition that could impact on the results of the study
  • Subject over 85 years of age (ocular pathology more common in this age group)
  • Subjects without adequate physical and mental capacity to enable participation in the study
  • Subject unwilling to participate
  • Systemic or topical medication known to influence visual function measures
  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: NCT01654159

Contacts
Contact: James S Wolffsohn, PhD +44(0)121 2044140 ext x j.s.w.wolffsohn@aston.ac.uk

Locations
United Kingdom
Birmingham Midland Eye Centre Not yet recruiting
Birmingham, West Midlands, United Kingdom, B18 7QH
Contact: Sunil Shah, FRCS    +44(0)1215076801 ext x    sunil.shah@doctors.org.uk   
Principal Investigator: Sunil Shah, FRCS         
Sponsors and Collaborators
Aston University
Investigators
Principal Investigator: Sunil Shah, FRCS Birmingham Midland Eye Centre
  More Information

No publications provided

Responsible Party: Aston University
ClinicalTrials.gov Identifier: NCT01654159     History of Changes
Other Study ID Numbers: IOL2012
Study First Received: July 17, 2012
Last Updated: July 15, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Aston University:
intraocular lenses
evaluation
cataract

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 28, 2014