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Enrolling by Invitation

NCT Number: NCT05670626

Correlation Between Preoperative Refraction and Anterior Segment Parameters With ICL Vault

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.

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Key information

Conditions

Refractive Errors Astigmatism Eye Diseases Myopia Myopic Astigmatism

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alwatany Eye Hospital

Cairo, Cairo Governorate, 00000, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Refractive Surgery

Procedure

Phakic implantable contact lens ( ICL)

Primary outcomes

  1. ICL vault size

    Time frame: 1 month

    assessment of ICL vault by scheimpflug image

  2. ICL Vault size

    Time frame: 6 months

    assessment of ICL vault by scheimpflug image

  3. Post Operative UCVA and BCVA

    Time frame: 1-3 days

    assessment of Post Operative visual acuity

  4. Post Operative UCVA and BCVA

    Time frame: 1 month

    assessment of Post Operative visual acuity

  5. Post Operative UCVA and BCVA

    Time frame: 6 months

    assessment of Post Operative visual acuity

  6. Post Operative IOP

    Time frame: 1 - 3 days

    assessment of post operative intraocular pressure

  7. Post Operative IOP

    Time frame: 1 month

    assessment of post operative intraocular pressure

  8. Post Operative IOP

    Time frame: 6 month

    assessment of post operative intraocular pressure

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study title

Correlation Between ICL Vault and Preoperative Refraction ( Spherical Equivalent) and Anterior Segment Parameters Measured by Optical Biometry and Scheimpflug Imaging

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 4, 2023
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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