Calculation of Intraocular Lens in High Myopic Cataractous PatientsNCT04952181
Comparison Between Different Investigations Used in Intraocular Lens Calculation in High Myopic Cataractous Patients
A study testing optical biometry and ultrasonic biometry in people with Calculation of Intraocular Lens in High Myopic Cataractous Patients, run by Sohag University.
Trial 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 Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Calculation of Intraocular Lens in High Myopic Cataractous Patients
- What is being tested?
- optical biometry and ultrasonic biometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jul 2021to Feb 2022
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet.
Usama A Mohamed, Professor contact
About this study
Official title: Optical Biometry Versus Ultrasonic Biometry in Intraocular Lens Calculation in High Myopic Cataractous Patients: A Comparative Study
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
Read the 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
- Being tested
- optical biometry, ultrasonic biometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
optical biometryDevice
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.
ultrasonic biometryDevice
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
| Study group | Role | What they receive |
|---|---|---|
| optical biometry | Experimental | Not described Receives: Device: optical biometry |
| ultrasonic biometry | Experimental | Not described Receives: Device: ultrasonic biometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: postoperative refraction 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study startJul 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Calculation of Intraocular Lens in High Myopic Cataractous PatientsStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Ahmed Okasha, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952181
- Sponsor's protocol ID
- Soh-Med-21-06-01
- Status last verified
- Jun 2021
- First submitted
- 27 Jun 2021
- Last updated
- 7 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 20447976Wang 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.
PubMed 22018365Olsen 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.
PubMed 17244216
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Biometry Versus Ultrasonic Biometry in Intraocular Lens Calculation in High Myopic Cataractous Patients: A Comparative Study
- ClinicalTrials.gov ID
- NCT04952181
- Acronym / sponsor ID
- Soh-Med-21-06-01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 7 Jul 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.
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
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| optical biometry | Experimental | Device: optical biometry |
| ultrasonic biometry | Experimental | Device: ultrasonic biometry |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
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 |
|---|---|---|
| optical biometryoptical 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. | Device | optical biometry |
| ultrasonic biometryultrasonic 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 | Device | ultrasonic biometry |
Primary outcome
desired post operative refraction
Time frame: postoperative refraction 1 month
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Background: PubMed 20447976Tappeiner 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.
- Background: PubMed 22018365Wang 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.
- Background: PubMed 17244216Olsen 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.
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.
Usama A Mohamed, Professor contact
Questions about this trial
What is this clinical trial studying?
A study testing optical biometry and ultrasonic biometry in people with Calculation of Intraocular Lens in High Myopic Cataractous Patients, run by Sohag University.
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 5 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 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Esraa A Okasha, Resident (01028909988, esraa011037@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
desired post operative refraction (time frame: postoperative refraction 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04952181, which also lists 3 linked publications.
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 7 Jul 2021.