Refractive ErrorsNCT05670626
Correlation Between Preoperative Refraction and Anterior Segment Parameters With ICL Vault
A study testing Refractive Surgery in people with Refractive Errors and Myopia, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
This prospective non-comparative interventional study aims to analyse the pre-operative factors affecting the range of optimal ICL vaulting. the main question is what is the correlation between age, gender, spherical equivalent, white to white, anterior chamber volume and depth and postoperative vault? participants… Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Refractive Errors, Myopia, Myopic Astigmatism
- What is being tested?
- Refractive Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Dec 2022to 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 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age:21 - 45 years old.
- High Myopia or Myopic astigmatism.
- Patients with stable preoperative refraction for the previous 12 months.
- Aqueous depth (ACD internal) = 2.8 mm or greater from the endothelial side using pentacam.
- Patients who are not fit for LASIK.
- No previous intraocular surgeries.
Who cannot join
- Patients with endothelial cell count < 2800 cells /mm2
- Patients with corneal opacities
- Patients with preoperative glaucoma, cataract, and retinal disease.
- Patients with any systemic diseases especially collagen diseases.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Correlation Between ICL Vault and Preoperative Refraction ( Spherical Equivalent) and Anterior Segment Parameters Measured by Optical Biometry and Scheimpflug Imaging
This prospective non-comparative interventional study aims to analyse the pre-operative factors affecting the range of optimal ICL vaulting. the main question is what is the correlation between age, gender, spherical equivalent, white to white, anterior chamber volume and depth and postoperative vault? participants will do preoperative investigations ( specular microscopy, pentacam and biometry ) then refractive surgery (ICL implantation) followed by follow-up visits to assess the post-operative ICL vault and visual outcome.
Read the detailed description
Procedure: Refractive error correction by implantable contact lens ( ICL) will be preceded by a Preoperative assessment of the patient's anterior segment using specular Microscopy, pentacam and biometry and full ophthalmic examination.
Post-operatively, visual acuity evaluation, intraocular pressure, and anterior and posterior segments examination using a slit lamp will be done on days 1 and 3 and then repeated after 1 month and 6 months Assessment of ICL vault measurement using pentacam scheimpflug imaging after 1 and 6 months will be done then a correlation between the ICL vault and the patient's refractive error and preoperative anterior segments parameters will be evaluated
- Conditions
- Refractive Errors, Myopia, Myopic Astigmatism
- Being tested
- Refractive Surgery
- Keywords
- Refractive surgery, Phakic intraocular lens, ICL vault
- Medical subject headings
- Refractive Errors, Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Refractive SurgeryProcedure or surgery
Phakic implantable contact lens ( ICL)
| Study group | Role | What they receive |
|---|---|---|
| non comparative interventional study | Other | patients with high refractive error will do phakic ICL after preoperative assessment of anterior segments parameters and post-operative ICL vault will be measured using pentacam Receives: Procedure: Refractive Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICL vault size
assessment of ICL vault by scheimpflug image
Measured: 1 month
ICL Vault size
assessment of ICL vault by scheimpflug image
Measured: 6 months
Post Operative UCVA and BCVA
assessment of Post Operative visual acuity
Measured: 1-3 days
Post Operative UCVA and BCVA
assessment of Post Operative visual acuity
Measured: 1 month
Post Operative UCVA and BCVA
assessment of Post Operative visual acuity
Measured: 6 months
Post Operative IOP
assessment of post operative intraocular pressure
Measured: 1 - 3 days
Post Operative IOP
assessment of post operative intraocular pressure
Measured: 1 month
Post Operative IOP
assessment of post operative intraocular pressure
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start14 Dec 2022
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive ErrorsStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nermine Said Aly Madkour, Kasr El Aini Hospital
- Investigators
- Adel M Fathy, Prof. DR, Study director, Faculty of medicine Kasr El AiniRamy R Fikry, Ass prof, Study director, Faculty of medicine Kasr El AiniMohamed A Anis, Ass Prof, Study director, Faculty of medicine Kasr El Aini
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670626
- Sponsor's protocol ID
- MD-360-2021
- Status last verified
- Mar 2025
- First submitted
- 11 Dec 2022
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between ICL Vault and Preoperative Refraction ( Spherical Equivalent) and Anterior Segment Parameters Measured by Optical Biometry and Scheimpflug Imaging
- ClinicalTrials.gov ID
- NCT05670626
- Acronym / sponsor ID
- MD-360-2021
- Conditions
- Refractive Errors, Myopia, Myopic Astigmatism
- Keywords
- Refractive surgery, Phakic intraocular lens, ICL vault
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 14 Dec 2022 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 4 Jan 2023 (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 prospective non-comparative interventional study aims to analyse the pre-operative factors affecting the range of optimal ICL vaulting. the main question is what is the correlation between age, gender, spherical equivalent, white to white, anterior chamber volume and depth and postoperative vault? participants will do preoperative investigations ( specular microscopy, pentacam and biometry ) then refractive surgery (ICL implantation) followed by follow-up visits to assess the post-operative ICL vault and visual outcome.
Detailed description
Procedure: Refractive error correction by implantable contact lens ( ICL) will be preceded by a Preoperative assessment of the patient's anterior segment using specular Microscopy, pentacam and biometry and full ophthalmic examination.
Post-operatively, visual acuity evaluation, intraocular pressure, and anterior and posterior segments examination using a slit lamp will be done on days 1 and 3 and then repeated after 1 month and 6 months Assessment of ICL vault measurement using pentacam scheimpflug imaging after 1 and 6 months will be done then a correlation between the ICL vault and the patient's refractive error and preoperative anterior segments parameters will be evaluated
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| non comparative interventional study | Other | Procedure: Refractive Surgerypatients with high refractive error will do phakic ICL after preoperative assessment of anterior segments parameters and post-operative ICL vault will be measured using pentacam |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age:21 - 45 years old.
- High Myopia or Myopic astigmatism.
- Patients with stable preoperative refraction for the previous 12 months.
- Aqueous depth (ACD internal) = 2.8 mm or greater from the endothelial side using pentacam.
- Patients who are not fit for LASIK.
Key exclusion criteria (4 listed)
- Patients with endothelial cell count < 2800 cells /mm2
- Patients with corneal opacities
- Patients with preoperative glaucoma, cataract, and retinal disease.
- Patients with any systemic diseases especially collagen diseases.
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 |
|---|---|---|
| Refractive SurgeryPhakic implantable contact lens ( ICL) | Procedure or surgery | non comparative interventional study |
Primary outcome
ICL vault size
Time frame: 1 month
assessment of ICL vault by scheimpflug image
ICL Vault size
Time frame: 6 months
assessment of ICL vault by scheimpflug image
Post Operative UCVA and BCVA
Time frame: 1-3 days
assessment of Post Operative visual acuity
Post Operative UCVA and BCVA
Time frame: 1 month
assessment of Post Operative visual acuity
Post Operative UCVA and BCVA
Time frame: 6 months
assessment of Post Operative visual acuity
Post Operative IOP
Time frame: 1 - 3 days
assessment of post operative intraocular pressure
Post Operative IOP
Time frame: 1 month
assessment of post operative intraocular pressure
Post Operative IOP
Time frame: 6 month
assessment of post operative intraocular pressure
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 13 Mar 2025.
- 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.
Adel M Fathy, Prof. DR study director
Faculty of medicine Kasr El Aini
Ramy R Fikry, Ass prof study director
Faculty of medicine Kasr El Aini
Mohamed A Anis, Ass Prof study director
Faculty of medicine Kasr El Aini
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Refractive Surgery in people with Refractive Errors and Myopia, run by Kasr El Aini Hospital 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 6 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 13 Mar 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICL vault size (time frame: 1 month). The study lists 8 primary outcomes in all. 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 Mar 2025.