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Comparison Between Different Investigations Used in Intraocular Lens Calculation in High Myopic Cataractous Patients

Primary Purpose

Calculation of Intraocular Lens in High Myopic Cataractous Patients

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
optical biometry
ultrasonic biometry
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Calculation of Intraocular Lens in High Myopic Cataractous Patients

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patients with simple cataract not associated with other pathologies suitable for phacoemulsification and 1ry IOL implantation With axial length (AXL) equal to or greater than 26.5mm

Exclusion Criteria:

  1. History of trauma
  2. Associated pathologies such as optic neuropathy, age related macular degeneration, macular edema, retinal detachment, , ocular inflammation, retinitis pigmentosa, proliferative diabetic retinopathy
  3. corneal opacities or irregularities, scars, dystrophy or ectasia
  4. Patients who underwent previous corneal surgery (including refractive surgery)
  5. Patients having intraoperative complications as inability to achieve secure 'in the bag' placement of the IOL (i.e. due to posterior capsule rupture, vitreous loss, weak zonules, or zonular rupture)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    optical biometry

    ultrasonic biometry

    Arm Description

    Outcomes

    Primary Outcome Measures

    desired post operative refraction
    detection of postoperative refraction by the use of autorefractor (one of the objective methods of assessment of refraction) after use of IOL power calculated by different investigations (optical vs ultrasonic)

    Secondary Outcome Measures

    Full Information

    First Posted
    June 27, 2021
    Last Updated
    July 4, 2021
    Sponsor
    Sohag University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04952181
    Brief Title
    Comparison Between Different Investigations Used in Intraocular Lens Calculation in High Myopic Cataractous Patients
    Official Title
    Optical Biometry Versus Ultrasonic Biometry in Intraocular Lens Calculation in High Myopic Cataractous Patients: A Comparative Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2021 (Anticipated)
    Primary Completion Date
    December 2021 (Anticipated)
    Study Completion Date
    February 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sohag University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    the purpose of the study is to compare the accuracy of optical and ultrasonic biometry in intraocular lens (IOL) calculation in high myopic cataractous patients
    Detailed Description
    Prospective interventional (QUASI experimental) comparative study This study will be conducted on high myopic cataractous patients scheduled for phacoemulsification and IOL implantation in department of ophthalmology, Sohag university patients will be divided into 2 groups one will be subjected to intraocular lens (IOL) calculation by optical biometry the second one will be subjected to intraocular lens (IOL) calculation by ultrasonic biometry postoperative auto refraction after I month

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Calculation of Intraocular Lens in High Myopic Cataractous Patients

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    optical biometry
    Arm Type
    Experimental
    Arm Title
    ultrasonic biometry
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    optical biometry
    Intervention Description
    optical biometry is a fast, noncontact method it uses the method of partial coherence interferometry (PCI) to measure the axial length (AXL), based on reflection of the interference signal of the retinal pigment epithelium.
    Intervention Type
    Device
    Intervention Name(s)
    ultrasonic biometry
    Intervention Description
    ultrasonic biometry is contact method depends on ultrasonic transducer producing thin sound beam travelling through different media of the eye when it faces interface of substance dissimilar from that it is travelling through part is reflecting and the other travel through the different substance
    Primary Outcome Measure Information:
    Title
    desired post operative refraction
    Description
    detection of postoperative refraction by the use of autorefractor (one of the objective methods of assessment of refraction) after use of IOL power calculated by different investigations (optical vs ultrasonic)
    Time Frame
    postoperative refraction 1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: patients with simple cataract not associated with other pathologies suitable for phacoemulsification and 1ry IOL implantation With axial length (AXL) equal to or greater than 26.5mm Exclusion Criteria: History of trauma Associated pathologies such as optic neuropathy, age related macular degeneration, macular edema, retinal detachment, , ocular inflammation, retinitis pigmentosa, proliferative diabetic retinopathy corneal opacities or irregularities, scars, dystrophy or ectasia Patients who underwent previous corneal surgery (including refractive surgery) Patients having intraoperative complications as inability to achieve secure 'in the bag' placement of the IOL (i.e. due to posterior capsule rupture, vitreous loss, weak zonules, or zonular rupture)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Esraa A Okasha, Resident
    Phone
    01028909988
    Email
    esraa011037@med.sohag.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Usama A Mohamed, Professor
    Phone
    01005470455

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20447976
    Citation
    Tappeiner C, Rohrer K, Frueh BE, Waelti R, Goldblum D. Clinical comparison of biometry using the non-contact optical low coherence reflectometer (Lenstar LS 900) and contact ultrasound biometer (Tomey AL-3000) in cataract eyes. Br J Ophthalmol. 2010 May;94(5):666-7. doi: 10.1136/bjo.2009.167700. No abstract available.
    Results Reference
    background
    PubMed Identifier
    22018365
    Citation
    Wang L, Shirayama M, Ma XJ, Kohnen T, Koch DD. Optimizing intraocular lens power calculations in eyes with axial lengths above 25.0 mm. J Cataract Refract Surg. 2011 Nov;37(11):2018-27. doi: 10.1016/j.jcrs.2011.05.042.
    Results Reference
    background
    PubMed Identifier
    17244216
    Citation
    Olsen T. Improved accuracy of intraocular lens power calculation with the Zeiss IOLMaster. Acta Ophthalmol Scand. 2007 Feb;85(1):84-7. doi: 10.1111/j.1600-0420.2006.00774.x.
    Results Reference
    background

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    Comparison Between Different Investigations Used in Intraocular Lens Calculation in High Myopic Cataractous Patients

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