CataractNCT05290896
Correlations Between Lens Star and Phacoemulsification.
A study testing Phacoemulsification in people with Cataract and Lens Diseases, run by Benha University at 1 site in Egypt.
Trial summary
To assess correlations between lens star biometry parameters and phacoemulsification in clinical practice. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cataract, Lens Diseases, Lens Opacities
- What is being tested?
- Phacoemulsification
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2022to 15 Sep 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients that will undergone phacoemulsification for their mild to moderate senile cataracts.
Who cannot join
- congenital and developmental cataract.
- cases with congenital lens anomalies as ectopia lentis and spheophakia.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ahmed Abdelshafy
Banhā, QA, 13511
Ahmed Abdelshafy, 01222328766, ahmad4lg@gmail.com
ahmad4lg@gmail.com
About this study
Official title: Correlations Between Lens Star Parameters and Phacoemulsification in Clinical Practice.
To assess correlations between lens star biometry parameters and phacoemulsification in clinical practice.
Read the detailed description
To analyze possible correlations between lens star biometry parameters and phacoemulsification in mild to moderate senile cataract.
- Conditions
- Cataract, Lens Diseases, Lens Opacities
- Being tested
- Phacoemulsification
- Keywords
- Cataract
- Medical subject headings
- Cataract, Lens Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhacoemulsificationDevice
Also called Phaco
Phacoemulsification for senile cataract.
| Study group | Role | What they receive |
|---|---|---|
| Lens star biometry | Other | Biometry done prior to phacoemulsification Receives: Device: Phacoemulsification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between parameters measured by lens star.
Anterior chamber depth, lens, axial length, keratometry readings and age of the patients.
Measured: Immediately before phacoemulsification surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start20 Feb 2022
- Primary completion30 Aug 2022 (estimated)
- Study completion15 Sep 2022 (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.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Senile cataract patients
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelshafy, Benha University
- Investigators
- Ahmed A Abdelshafy, MD, Principal investigator, Benha UniversityMarwa A Abdelshafy, MD, Study director, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05290896
- Sponsor's protocol ID
- Rc-3-29
- Status last verified
- Mar 2022
- First submitted
- 12 Mar 2022
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlations Between Lens Star Parameters and Phacoemulsification in Clinical Practice.
- ClinicalTrials.gov ID
- NCT05290896
- Acronym / sponsor ID
- Rc-3-29
- Conditions
- Cataract, Lens Diseases, Lens Opacities
- Keywords
- Cataract
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 20 Feb 2022 (actual)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 15 Sep 2022 (estimated)
- First posted
- 22 Mar 2022 (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.
To assess correlations between lens star biometry parameters and phacoemulsification in clinical practice.
Detailed description
To analyze possible correlations between lens star biometry parameters and phacoemulsification in mild to moderate senile cataract.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Senile cataract patients
| Arm | Type | Receives |
|---|---|---|
| Lens star biometry | Other | Device: PhacoemulsificationBiometry done prior to phacoemulsification |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients that will undergone phacoemulsification for their mild to moderate senile cataracts.
Key exclusion criteria (2 listed)
- congenital and developmental cataract.
- cases with congenital lens anomalies as ectopia lentis and spheophakia.
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 |
|---|---|---|
| PhacoemulsificationAlso: PhacoPhacoemulsification for senile cataract. | Device | Lens star biometry |
Primary outcome
Correlation between parameters measured by lens star.
Time frame: Immediately before phacoemulsification surgery
Anterior chamber depth, lens, axial length, keratometry readings and age of the patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
Ahmed A Abdelshafy, MD principal investigator
Benha University
Marwa A Abdelshafy, MD study director
Benha University
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 in people with Cataract and Lens Diseases, run by Benha 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 2 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 22 Mar 2022. 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 Ahmed Abdelshafy, MD (01222328766, ahmad4lg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between parameters measured by lens star. (time frame: Immediately before phacoemulsification surgery). 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 22 Mar 2022.