Correlation Between Preoperative Refraction and Anterior Segment Parameters With ICL Vault
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Refractive Surgery.
- Who it may be relevant to
- Registry conditions: Refractive Errors, Myopia, Myopic Astigmatism. Basic parameters: 21 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Correlation Between ICL Vault and Preoperative Refraction ( Spherical Equivalent) and Anterior Segment Parameters Measured by Optical Biometry and Scheimpflug Imaging
Overview
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
Interventions
- Procedure Refractive Surgery
Phakic implantable contact lens ( ICL)
Primary outcome measures
- ICL vault size [Time frame: 1 month]
- ICL Vault size [Time frame: 6 months]
- Post Operative UCVA and BCVA [Time frame: 1-3 days]
- Post Operative UCVA and BCVA [Time frame: 1 month]
- Post Operative UCVA and BCVA [Time frame: 6 months]
- Post Operative IOP [Time frame: 1 - 3 days]
- Post Operative IOP [Time frame: 1 month]
- Post Operative IOP [Time frame: 6 month]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Egypt · 1 center
- Alwatany Eye Hospital — Cairo
Identifiers
NCT: NCT05670626 · MD-360-2021