N/A
N=448
Safety and Suitability of ICL for Correction of Refractive Errors Without the Use of Dispersive OVDs
Refractive Errors · Myopia · Myopic Astigmatism · Hypermetropia
Bottom Line
View on ClinicalTrials.gov: NCT06371079 ↗Enrolled (actual)
448
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Unaided Visual Acuity After the Procedure — 0.264; 0.227 LogMar vision
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- phakic intraocular lens implantation traditional (Device); phakic intraocular lens implantation reduced OVD (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Loay Abdulmutalib Almusawi
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Unaided Visual Acuity After the Procedure |
0.264; 0.227 | — |
| SECONDARY Intraocular Pressure Postoperatively |
17.44; 17.80 | — |
| SECONDARY Specular Microscopy Parameter: Endothelial Cell Density |
2785.4; 2851.0 | — |
| SECONDARY Specular Microscopy Parameter: Endothelial Cells Hexagonality |
58.69; 57.93 | — |
| SECONDARY Specular Microscopy Parameter: Coefficient of Variation of Corneal Endothelial Cells |
27.37; 29.64 | — |
Summary
The goal of this observational study is to test whether surgeries for lenses designed to be implanted in the eye to correct refractive error can be done without the need for using viscoelastic substances that are used routinely nowadays to make it easier to introduce them inside the human eye and protect the inside of the eye during the operation.
The main question it aims to answer is that is it safe to do the surgery without using them? to answer this question researchers will access recorded data of patients that underwent refractive surgeries in a private clinic since 2017 and compare them as two groups: those who underwent the traditional procedures and those who had it without the use of dispersive viscoelastics in regard to their vision before and after surgery, their ocular pressure and biomicroscopic analysis of the inside of their corneas before and after surgery.
Eligibility Criteria
- Inclusion Criteria:
- patients with refractive errors and stable refraction seeking refractive surgery who are fit for phakic IOL (intraocular lens) implantation and having reasonable improvement of visual acuity with refractive correction.
Exclusion Criteria
- patients with severe ocular surface disease, unstable refraction, glaucoma, cataract, retinal detachment and uveitis.
Data sourced from ClinicalTrials.gov (NCT06371079). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.