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Enrolling by invitationNCT05670626Updated Mar 13, 2025

Correlation Between Preoperative Refraction and Anterior Segment Parameters With ICL Vault

An interventional study of Refractive Surgery in Refractive Errors, Myopia and Myopic Astigmatism, sponsored by Kasr El Aini Hospital. Enrolling by invitation at 1 site in Egypt. Open to participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-13.

Sponsored by Kasr El Aini Hospital · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year 1 month ago, but the record still lists the study as enrolling by invitation.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
21 Years to 45 Years
Sex
All
01

Study 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 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

02

Conditions studied

  • Refractive Errors
  • Myopia
  • Myopic Astigmatism

Keywords

  • Refractive surgery
  • Phakic intraocular lens
  • ICL vault
03

In context

Refractive Errors

420 studies on the registry are indexed under Refractive Errors; 59 are open to participants now.

This study's planned enrollment of 40 is below the median of 76 across 301 interventional studies indexed under Refractive Errors.

Browse Refractive Errors studies →

Lead sponsor

Kasr El Aini Hospital is the lead sponsor of 287 studies on the registry; 34 are open to participants now.

Browse Kasr El Aini Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Other
    non comparative interventional study

    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

    Procedure: Refractive Surgery

Interventions

  • ProcedureRefractive Surgery

    Phakic implantable contact lens ( ICL)

06

What researchers measure

Primary outcomes

  1. ICL vault size

    assessment of ICL vault by scheimpflug image

    Time frame: 1 month

  2. ICL Vault size

    assessment of ICL vault by scheimpflug image

    Time frame: 6 months

  3. Post Operative UCVA and BCVA

    assessment of Post Operative visual acuity

    Time frame: 1-3 days

  4. Post Operative UCVA and BCVA

    assessment of Post Operative visual acuity

    Time frame: 1 month

  5. Post Operative UCVA and BCVA

    assessment of Post Operative visual acuity

    Time frame: 6 months

  6. Post Operative IOP

    assessment of post operative intraocular pressure

    Time frame: 1 - 3 days

  7. Post Operative IOP

    assessment of post operative intraocular pressure

    Time frame: 1 month

  8. Post Operative IOP

    assessment of post operative intraocular pressure

    Time frame: 6 month

07

Study locations

1 site
  • Alwatany Eye Hospital
    Cairo, 00000, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2022 (actual). Primary completion is estimated for Oct 2025, 34 months after the start.

Of 57 non-industry interventional studies with no phase under Refractive Errors, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 47. This study's planned 34 months is close to that.

Counting every sponsor, half of 172 studies reached it within 7 months; a quarter within 2 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 11, 2022
First posted
Jan 4, 2023
StartActual
Dec 14, 2022
Primary completionEst.
Oct 2025
CompletionEst.
Dec 2025
Last update
Mar 13, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05670626
Lead sponsor
Kasr El Aini Hospital
Responsible party
Nermine Said Aly Madkour (ophthalmology consultant, Kasr El Aini Hospital) — Principal investigator
First posted
Jan 4, 2023
Start date
Dec 14, 2022
Primary completion
Oct 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Mar 13, 2025

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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