CataractNCT04701255
Postoperative Total Wavefront Pattern Between Two Types of Intraocular Lenses Implanted in Cataract Surgery
A study testing phacoemulsification with intraocular lens implantation and ocular aberrometer assesment in people with Cataract, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- phacoemulsification with intraocular lens implantation and ocular aberrometer assesment
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Nov 2020to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
facultyof medicine, Cairo university
Cairo, 12563
About this study
Official title: Difference in Postoperative Total Wavefront Pattern Between Aspheric and Negative Spherical Aberration Intraocular Lenses Implanted in Cataract Surgery
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.
Read more
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.
Read the 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.
- Conditions
- Cataract
- Being tested
- phacoemulsification with intraocular lens implantation, ocular aberrometer assesment
- Keywords
- aberration-free, negative spherical aberration, phacoemulsification, intraocular lens, wavefront
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phacoemulsification with intraocular lens implantationProcedure or surgery
treatment of cataract by phacoemulsification procedure and implantation of different types of IOLs.
ocular aberrometer assesmentDevice
evaluate total ocular wavefront, corneal wavefront \& internal wavefront (High order aberrations ) post operative by corneal tomography and aberrometer
| Study group | Role | What they receive |
|---|---|---|
| aberration-free IOL | Experimental | 20 human eyes with aberration-free intraocular lens Implantation after phacoemulsification cataract surgery Receives: Procedure: phacoemulsification with intraocular lens implantation; Device: ocular aberrometer assesment |
| negative spherical aberration IOL | Active comparator | 20 human eyes with negative spherical aberration intraocular lens Implantation after phacoemulsification cataract surgery Receives: Procedure: phacoemulsification with intraocular lens implantation; Device: ocular aberrometer assesment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal, Ocular, and Internal spherical aberrations
assessment of ocular, corneal \& internal wavefront by aberrometer \& corneal tomography
Measured: 1 month postoperative
Secondary outcomes (2)
corneal wavefront changes
- Compare pre-operative and post-operative corneal spherical aberrations of every patient and evaluate any significant changes.
Measured: 1 month postoperative
near vision addition
the plus lenses needed to be add to correct near vision which reflect the depth of focus of the IOL implanted
Measured: 1 month postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start9 Nov 2020
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 40 human eyes undergoing phacoemulsification with intraocular lens implantation
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Ghonaim, Cairo University
- Investigators
- Aya G Ibrahim, MBBCh, Principal investigator, Dar El Oyoun ophthalmology hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701255
- Sponsor's protocol ID
- 336-2020
- Status last verified
- Jan 2021
- First submitted
- 6 Jan 2021
- Last updated
- 13 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Difference in Postoperative Total Wavefront Pattern Between Aspheric and Negative Spherical Aberration Intraocular Lenses Implanted in Cataract Surgery
- ClinicalTrials.gov ID
- NCT04701255
- Acronym / sponsor ID
- 336-2020
- Conditions
- Cataract
- Keywords
- aberration-free, negative spherical aberration, phacoemulsification, intraocular lens, wavefront
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 8 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 40 human eyes undergoing phacoemulsification with intraocular lens implantation
| Arm | Type | Receives |
|---|---|---|
| aberration-free IOL | Experimental | Procedure: phacoemulsification with intraocular lens implantation, Device: ocular aberrometer assesment20 human eyes with aberration-free intraocular lens Implantation after phacoemulsification cataract surgery |
| negative spherical aberration IOL | Active comparator | Procedure: phacoemulsification with intraocular lens implantation, Device: ocular aberrometer assesment20 human eyes with negative spherical aberration intraocular lens Implantation after phacoemulsification cataract surgery |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (8 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phacoemulsification with intraocular lens implantationtreatment of cataract by phacoemulsification procedure and implantation of different types of IOLs. | Procedure or surgery | aberration-free IOL, negative spherical aberration IOL |
| ocular aberrometer assesmentevaluate total ocular wavefront, corneal wavefront \& internal wavefront (High order aberrations ) post operative by corneal tomography and aberrometer | Device | aberration-free IOL, negative spherical aberration IOL |
Primary outcome
Corneal, Ocular, and Internal spherical aberrations
Time frame: 1 month postoperative
assessment of ocular, corneal \& internal wavefront by aberrometer \& corneal tomography
2 secondary outcomes
corneal wavefront changes
Time frame: 1 month postoperative
near vision addition
Time frame: 1 month postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aya G Ibrahim, MBBCh principal investigator
Dar El Oyoun ophthalmology hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing phacoemulsification with intraocular lens implantation and ocular aberrometer assesment in people with Cataract, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed H Hosny, professor (00201000007675, hosnylasik@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal, Ocular, and Internal spherical aberrations (time frame: 1 month postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021; AzTrials last refreshed its copy on 27 Oct 2026.