Postoperative Total Wavefront Pattern Between Two Types of Intraocular Lenses Implanted in Cataract Surgery
Primary Purpose
Cataract
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
phacoemulsification with intraocular lens implantation
ocular aberrometer assesment
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring aberration-free, negative spherical aberration, phacoemulsification, intraocular lens, wavefront
Eligibility Criteria
Inclusion Criteria:
1-All patients with written informed consent, between the age of 21 -75 years who will undergo phacoemulsification procedure with intraocular lens implantation of one of the targeted lenses in the study
Exclusion Criteria:
- Previous corneal intervention or refractive surgery.
- Persistent Corneal edema (epithelial or stromal).
- Co-existing corneal pathology.
- Ocular surface disease & Dry eye syndrome.
- Posterior capsular opacity .
- Anterior capsular contraction (phimosis).
- Ocular inflammation.
- Co-existing Vitreoretinal diseases.
Sites / Locations
- facultyof medicine, Cairo universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
aberration-free IOL
negative spherical aberration IOL
Arm Description
20 human eyes with aberration-free intraocular lens Implantation after phacoemulsification cataract surgery
20 human eyes with negative spherical aberration intraocular lens Implantation after phacoemulsification cataract surgery
Outcomes
Primary Outcome Measures
Corneal, Ocular, and Internal spherical aberrations
assessment of ocular, corneal & internal wavefront by aberrometer & corneal tomography
Secondary Outcome Measures
corneal wavefront changes
• Compare pre-operative and post-operative corneal spherical aberrations of every patient and evaluate any significant changes.
near vision addition
the plus lenses needed to be add to correct near vision which reflect the depth of focus of the IOL implanted
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04701255
Brief Title
Postoperative Total Wavefront Pattern Between Two Types of Intraocular Lenses Implanted in Cataract Surgery
Official Title
Difference in Postoperative Total Wavefront Pattern Between Aspheric and Negative Spherical Aberration Intraocular Lenses Implanted in Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 9, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
With the advancement of cataract eye surgery and wavefront sensors, the previously unquantifiable refractive measurements have been identified and the high order aberrations have shown their effect on high resolution imaging.
In the human phakic eye, the shape of the normal cornea induces average positive spherical aberration and remains unchanged over time, whereas the crystalline lens has a negative spherical aberration. As a result, overall spherical aberration in the young eye is low.
However, the compensation slowly decreases with the aging lens and is fully lost after cataract extraction and implantation of a standard intraocular lens.
Optical studies showed that conventional biconvex spherical intraocular lenses add their intrinsic positive spherical aberration to the positive spherical aberration of the cornea resulting in image imperfection and blur. As a useful side effect, this also increases the depth of focus -often referred to as pseudo-accommodation.
New Aspheric intraocular lenses designs currently in use impart negative spherical aberration, about 0.17 to 0.20 microns of negative spherical aberration. This added negative spherical aberration partially corrects the average amount of corneal positive spherical aberration & compensate for its effect. Our study will include (FocusForce foldable aspheric intraocular lens, Bausch & Lomb, New Jersey, USA) as an example of this type of negative spherical aberration intraocular lenses.
In order to improve retinal image quality without compromising depth of field, or introducing other aberrations, aberration-free aspheric intraocular lenses were developed with no inherent spherical aberration.
The other intraocular lens targeted in our study (Akreos AO Microincision lens, Bausch & Lomb, New Jersey, USA) is an example of this type of IOLs.
Detailed Description
A customized correction for the individual eye seems to be the most promising solution for tailored correction of spherical aberration.
On the other hand, Wave front analysis of the ocular optical system has increased our knowledge of the aberrations in the eye. The importance of measuring optical aberrations lies not only in the presence of natural aberrations in the human eye, but also in its usefulness for evaluating individual surgical outcomes. By using Zernike polynomials, the aberrations of the ocular system can be characterized. Zernike coefficients of the higher-order aberrations can be derived from corneal topographic data. And for those generated by the whole optical system of the eye can be derived from aberrometry.
With current small-incision cataract surgery, it has been reported that the average postoperative corneal topography does not differ significantly from average preoperative corneal topography, so in our study we will focus on the ocular & internal wave front changes.
With the high resolution pyramid wavefront sensor incorporated in (SCHWIND PERAMIS®, topography and Aberrometry, Kleinostheim, Germany) we will evaluate and compare the total ocular wave front and the corneal wave front in our study to identify and estimate the internal aberrations . This new sensor uses an extended source instead of a point-like source avoiding in this manner the oscillation of the pyramid.
SCHWIND PERAMIS evaluates the ocular wave front aberrations with 45,000 measuring points - without any overlap and with clear assignment of each point & records 33 images per second and automatically selects the image with the best measurement. Together with real-time measurement, this ensures a new level of detail resolution and precision. SCHWIND PERAMIS can also be used to compare a patient's corneal and ocular wave front data. The direct comparison provides information about whether a visual defect is located on the surface of the cornea or within the eye itself, thus allowing us to identify and evaluate internal aberrations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
aberration-free, negative spherical aberration, phacoemulsification, intraocular lens, wavefront
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
40 human eyes undergoing phacoemulsification with intraocular lens implantation
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
aberration-free IOL
Arm Type
Experimental
Arm Description
20 human eyes with aberration-free intraocular lens Implantation after phacoemulsification cataract surgery
Arm Title
negative spherical aberration IOL
Arm Type
Active Comparator
Arm Description
20 human eyes with negative spherical aberration intraocular lens Implantation after phacoemulsification cataract surgery
Intervention Type
Procedure
Intervention Name(s)
phacoemulsification with intraocular lens implantation
Intervention Description
treatment of cataract by phacoemulsification procedure and implantation of different types of IOLs.
Intervention Type
Device
Intervention Name(s)
ocular aberrometer assesment
Intervention Description
evaluate total ocular wavefront, corneal wavefront & internal wavefront (High order aberrations ) post operative by corneal tomography and aberrometer
Primary Outcome Measure Information:
Title
Corneal, Ocular, and Internal spherical aberrations
Description
assessment of ocular, corneal & internal wavefront by aberrometer & corneal tomography
Time Frame
1 month postoperative
Secondary Outcome Measure Information:
Title
corneal wavefront changes
Description
• Compare pre-operative and post-operative corneal spherical aberrations of every patient and evaluate any significant changes.
Time Frame
1 month postoperative
Title
near vision addition
Description
the plus lenses needed to be add to correct near vision which reflect the depth of focus of the IOL implanted
Time Frame
1 month postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
1-All patients with written informed consent, between the age of 21 -75 years who will undergo phacoemulsification procedure with intraocular lens implantation of one of the targeted lenses in the study
Exclusion Criteria:
Previous corneal intervention or refractive surgery.
Persistent Corneal edema (epithelial or stromal).
Co-existing corneal pathology.
Ocular surface disease & Dry eye syndrome.
Posterior capsular opacity .
Anterior capsular contraction (phimosis).
Ocular inflammation.
Co-existing Vitreoretinal diseases.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammed H Hosny, professor
Phone
00201000007675
Email
hosnylasik@live.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aya G Ibrahim, MBBCh
Organizational Affiliation
Dar El Oyoun ophthalmology hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
facultyof medicine, Cairo university
City
Cairo
ZIP/Postal Code
12563
Country
Egypt
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
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Postoperative Total Wavefront Pattern Between Two Types of Intraocular Lenses Implanted in Cataract Surgery
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