Ultrasound BiomicroscopyNCT07769944
Ultrasound Biomicroscopic Assessment of Intraocular Lens Tilt and Decenteration After Phacoemulsification
An observational study of Ultrasound Biomicroscopy and Intraocular Lens, run by Sohag University at 1 site in Egypt.
Trial summary
This study aims to assess intraocular lens (IOL) tilt and decenteration by means of ultrasound biomicroscopy after phacoemulsification. Read more about this study
- Who is it for?
- Ages Up to 45 years
- Conditions the study is for
- Ultrasound Biomicroscopy, Intraocular Lens, Tilt
- What is being tested?
- Ultrasound biomicroscopy
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2025to 1 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: A prospective, observational, hospital-based study which will be conducted in the Department of Ophthalmology, Sohag University Hospital, Egypt.
Who may be able to join
- Both sexes.
- Patients with senile cataract prepared for phacoemulsification and IOL implantation.
Who cannot join
- Age <45 years.
- Complicated ataract.
- Coexisting ocular disorders (Glaucoma, Pseudoexfoliation Syndrome, Sublaxation, Chronic Iridocyclitis).
- Previous ocular surgery.
- Complicated phacoemulsification.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University
Sohag, Sohag Governorate, 82511
Mennatullah A Farrag, MBBCH, 00201129595307, menaa.adel@med.sohag.edu.eg
Mohamed A Abdellatif, MD
About this study
This study aims to assess intraocular lens (IOL) tilt and decenteration by means of ultrasound biomicroscopy after phacoemulsification.
Read the detailed description
Ultrasound biomicroscopy (UBM) is a non-invasive technique that uses high-frequency ultrasound to image the anterior segment of the eye.
It can help as a diagnostic procedure in eyelid and anterior segment (cornea, conjunctiva, sclera, iris, ciliary body) pathology. It is a vital tool in evaluating anterior segment cysts or tumors and their diagnosis, evolution, and treatment.
IOL tilt and decentration could be secondary to various aetiologies. The extent and direction of preoperative crystalline lens tilt have been demonstrated to be strongly correlated with postoperative tilt. Asymmetrical IOL fixation (partly in bag and partly in sulcus) and capsular tear during capsulorrhexis were reported as some causative factors to IOL tilt and decentration.
- Being tested
- Ultrasound biomicroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound biomicroscopyDevice
Scanning is conducted with the non-dilated eye in a central position and the patient in the supine position. A drop of a topical anesthetic agent (benoxinate hydrochloride) is applied to both eyes.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients with implanted hydrophilic intraocular lens (IOL). Receives: Device: Ultrasound biomicroscopy | |
| Group 2 | Patients with implanted hydrophobic intraocular lens (IOL). Receives: Device: Ultrasound biomicroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of intraocular lens tilt
Measurement of intraocular lens (IOL) tilt. The intraocular lens (IOL) position was measured as the Anterior Chamber Depth (ACD), defined as the distance between the anterior border of the hyperreflective line marking the central posterior corneal surface and the anterior IOL optic surface at the centre of the pupillary space.
Measured: Six months after surgery
Secondary outcomes (1)
Measurement of intraocular lens decenteration
Anterior Chamber Depth (ACD) was determined from the central inner corneal surface, perpendicular to the corneal surface to the most anteriorly visible part of the intraocular lens (IOL). A line (line AB) was drawn between the two scleral spurs (SSs), as the base line of reference for IOL position. Two perpendicular lines were drawn from both optical endpoints of the IOL (C and D) to the base line with intersection points (E and F). IOL decentration was equal to half of the differences between distance AE and FB, i.e. IOL decentration = (|AE-FB|) / 2.
Measured: Six months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start1 Oct 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound BiomicroscopyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Menantallah Adel Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07769944
- Sponsor's protocol ID
- Soh-Med-26-6-6MS
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Biomicroscopic Assessment of Intraocular Lens Tilt and Decenteration After Phacoemulsification
- ClinicalTrials.gov ID
- NCT07769944
- Acronym / sponsor ID
- Soh-Med-26-6-6MS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 18 Aug 2026 (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.
This study aims to assess intraocular lens (IOL) tilt and decenteration by means of ultrasound biomicroscopy after phacoemulsification.
Detailed description
Ultrasound biomicroscopy (UBM) is a non-invasive technique that uses high-frequency ultrasound to image the anterior segment of the eye.
It can help as a diagnostic procedure in eyelid and anterior segment (cornea, conjunctiva, sclera, iris, ciliary body) pathology. It is a vital tool in evaluating anterior segment cysts or tumors and their diagnosis, evolution, and treatment.
IOL tilt and decentration could be secondary to various aetiologies. The extent and direction of preoperative crystalline lens tilt have been demonstrated to be strongly correlated with postoperative tilt. Asymmetrical IOL fixation (partly in bag and partly in sulcus) and capsular tear during capsulorrhexis were reported as some causative factors to IOL tilt and decentration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Device: Ultrasound biomicroscopyPatients with implanted hydrophilic intraocular lens (IOL). |
| Group 2 | – | Device: Ultrasound biomicroscopyPatients with implanted hydrophobic intraocular lens (IOL). |
Who may qualify
- Ages
- Up to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- A prospective, observational, hospital-based study which will be conducted in the Department of Ophthalmology, Sohag University Hospital, Egypt.
Key inclusion criteria (2 listed)
- Both sexes.
- Patients with senile cataract prepared for phacoemulsification and IOL implantation.
Key exclusion criteria (5 listed)
- Age <45 years.
- Complicated ataract.
- Coexisting ocular disorders (Glaucoma, Pseudoexfoliation Syndrome, Sublaxation, Chronic Iridocyclitis).
- Previous ocular surgery.
- Complicated phacoemulsification.
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 |
|---|---|---|
| Ultrasound biomicroscopyScanning is conducted with the non-dilated eye in a central position and the patient in the supine position. A drop of a topical anesthetic agent (benoxinate hydrochloride) is applied to both eyes. | Device | Group 1, Group 2 |
Primary outcome
Measurement of intraocular lens tilt
Time frame: Six months after surgery
Measurement of intraocular lens (IOL) tilt. The intraocular lens (IOL) position was measured as the Anterior Chamber Depth (ACD), defined as the distance between the anterior border of the hyperreflective line marking the central posterior corneal surface and the anterior IOL optic surface at the centre of the pupillary space.
1 secondary outcome
Measurement of intraocular lens decenteration
Time frame: Six months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasound Biomicroscopy and Intraocular Lens, run by Sohag 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 2 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: looking for participants now, as of the sponsor's last update on 18 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mennatullah A Farrag, MBBCH (00201129595307, menaa.adel@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of intraocular lens tilt (time frame: Six months after 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 18 Aug 2026.