Assessment of Visual Function and Optics in Intraocular Lenses

Sponsor
Aston University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT01654159
Collaborator
(none)
500
1
3
135
3.7

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Procedure: Monofocal IOL
  • Procedure: Multifocal IOL
  • Procedure: Toric IOL
N/A

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Evaluating Subjective and Objective Performance of Instrumentation Used and Devices Implanted in Cataract Surgery
Actual Study Start Date :
Sep 1, 2013
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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

    Outcome Measures

    Primary Outcome Measures

    1. Unaided distance and near vision [Measured at 3-6 months after surgery]

      Visual Acuity (logMAR)

    Secondary Outcome Measures

    1. Patient Satisfaction [Measured at 3-6 months after surgery]

      NAVQ score

    2. Residual refraction [Measured at 3-6 months after surgery]

      Autorefraction / subjective refraction

    3. Aberrations [Measured at 3-6 months after surgery]

      Aberrometry

    4. Corrected distance and near acuity [Measured at 3-6 months after surgery]

      Acuity (logMAR)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Birmingham Midland Eye Centre Birmingham West Midlands United Kingdom B18 7QH

    Sponsors and Collaborators

    • Aston University

    Investigators

    • Principal Investigator: Sunil Shah, FRCS, Birmingham Midland Eye Centre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aston University
    ClinicalTrials.gov Identifier:
    NCT01654159
    Other Study ID Numbers:
    • IOL2012
    First Posted:
    Jul 31, 2012
    Last Update Posted:
    Feb 17, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Aston University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 17, 2022