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
About this trial
This is an interventional other trial for Calculation of Intraocular Lens in High Myopic Cataractous Patients
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)
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
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
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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
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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
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Comparison Between Different Investigations Used in Intraocular Lens Calculation in High Myopic Cataractous Patients
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