Corneal Endothelial CellsNCT06849375
Corneal Endothelial Assessment After Posterior Chamber Phakic Intraocular Lens Implantation
A study testing phakic IOL implantation in people with Corneal Endothelial Cells, run by Sohag University at 1 site in Egypt.
Trial summary
our primary aim of the work to assess the effect of phakic IOL implantation on corneal endothelium. we also used the specular microscope to assess the corneal endothelium Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Corneal Endothelial Cells
- What is being tested?
- phakic IOL implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 10 May 2024to 20 Dec 2025
- Phase
- Interventional
- 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 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Our inclusion criteria include: adults 18-35 years of age, myopia ˃ 6 D , anterior chamber depth (ACD) 2.85 mm or greater , an endothelial cell count of ≥ 2000 cells/mm2 and stable refractive history within 0.5 diopter for 1 year.
Who cannot join
- anterior chamber depth from endothelium < 2.85 mm, previous or current systemic or eye disease , surgery or trauma, pregnancy and nursing.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alahmady H Alsamman, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag, Sohag Governorate
Magdy M Amin, Professor
About this study
our primary aim of the work to assess the effect of phakic IOL implantation on corneal endothelium. we also used the specular microscope to assess the corneal endothelium
- Conditions
- Corneal Endothelial Cells
- Being tested
- phakic IOL implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phakic IOL implantationProcedure or surgery
specular microscopy examination to assess endothelial cells before and after phakic IOL implantation
| Study group | Role | What they receive |
|---|---|---|
| group who implant phakic IOL | Other | specular microscopy examination to assess the endothelial cells before and after phakic IOL implantation Receives: Procedure: phakic IOL implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
corneal endothelial cells assessment
specular micrioscopy examination before and after phakic IOL implantation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start10 May 2024
- Primary completion20 Dec 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Corneal Endothelial CellsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Mahmoud Abdelhameed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06849375
- Sponsor's protocol ID
- Soh-Med--25-1-11MS
- Status last verified
- Feb 2025
- First submitted
- 7 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Reinstein DZ, MacGregor C, Archer TJ, Gupta R, Potter JG. A review of posterior chamber phakic intraocular lenses. Curr Opin Ophthalmol. 2024 Mar 1;35(2):138-146. doi: 10.1097/ICU.0000000000001018. Epub 2023 Dec 6.
PubMed 38059758Taneri S, Dick HB. Initial clinical outcomes of two different phakic posterior chamber IOLs for the correction of myopia and myopic astigmatism. Graefes Arch Clin Exp Ophthalmol. 2022 May;260(5):1763-1772. doi: 10.1007/s00417-021-05465-w. Epub 2021 Nov 6.
PubMed 34741659Chaurasia S, Vanathi M. Specular microscopy in clinical practice. Indian J Ophthalmol. 2021 Mar;69(3):517-524. doi: 10.4103/ijo.IJO_574_20.
PubMed 33595465Sridhar MS. Anatomy of cornea and ocular surface. Indian J Ophthalmol. 2018 Feb;66(2):190-194. doi: 10.4103/ijo.IJO_646_17.
PubMed 29380756DelMonte DW, Kim T. Anatomy and physiology of the cornea. J Cataract Refract Surg. 2011 Mar;37(3):588-98. doi: 10.1016/j.jcrs.2010.12.037.
PubMed 21333881
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Endothelial Assessment After Posterior Chamber Phakic Intraocular Lens Implantation
- ClinicalTrials.gov ID
- NCT06849375
- Acronym / sponsor ID
- Soh-Med--25-1-11MS
- Conditions
- Corneal Endothelial Cells
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 10 May 2024 (actual)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 27 Feb 2025 (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.
our primary aim of the work to assess the effect of phakic IOL implantation on corneal endothelium. we also used the specular microscope to assess the corneal endothelium
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group who implant phakic IOL | Other | Procedure: phakic IOL implantationspecular microscopy examination to assess the endothelial cells before and after phakic IOL implantation |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Our inclusion criteria include: adults 18-35 years of age, myopia ˃ 6 D , anterior chamber depth (ACD) 2.85 mm or greater , an endothelial cell count of ≥ 2000 cells/mm2 and stable refractive history within 0.5 diopter for 1 year.
Key exclusion criteria (1 listed)
- anterior chamber depth from endothelium < 2.85 mm, previous or current systemic or eye disease , surgery or trauma, pregnancy and nursing.
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 |
|---|---|---|
| phakic IOL implantationspecular microscopy examination to assess endothelial cells before and after phakic IOL implantation | Procedure or surgery | group who implant phakic IOL |
Primary outcome
corneal endothelial cells assessment
Time frame: 1 year
specular micrioscopy examination before and after phakic IOL implantation
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 27 Feb 2025.
- Background: PubMed 38059758Reinstein DZ, MacGregor C, Archer TJ, Gupta R, Potter JG. A review of posterior chamber phakic intraocular lenses. Curr Opin Ophthalmol. 2024 Mar 1;35(2):138-146. doi: 10.1097/ICU.0000000000001018. Epub 2023 Dec 6.
- Background: PubMed 34741659Taneri S, Dick HB. Initial clinical outcomes of two different phakic posterior chamber IOLs for the correction of myopia and myopic astigmatism. Graefes Arch Clin Exp Ophthalmol. 2022 May;260(5):1763-1772. doi: 10.1007/s00417-021-05465-w. Epub 2021 Nov 6.
- Background: PubMed 33595465Chaurasia S, Vanathi M. Specular microscopy in clinical practice. Indian J Ophthalmol. 2021 Mar;69(3):517-524. doi: 10.4103/ijo.IJO_574_20.
- Background: PubMed 29380756Sridhar MS. Anatomy of cornea and ocular surface. Indian J Ophthalmol. 2018 Feb;66(2):190-194. doi: 10.4103/ijo.IJO_646_17.
- Background: PubMed 21333881DelMonte DW, Kim T. Anatomy and physiology of the cornea. J Cataract Refract Surg. 2011 Mar;37(3):588-98. doi: 10.1016/j.jcrs.2010.12.037.
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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.
Alahmady H Alsamman, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing phakic IOL implantation in people with Corneal Endothelial Cells, 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 1 inclusion and 1 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 27 Feb 2025. 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 Noha M Abdelhameed, Resident (+20 01005156393, mnoha0421@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
corneal endothelial cells assessment (time frame: 1 year). 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 NCT06849375, which also lists 5 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 27 Feb 2025.