MedTrace Logo

Safety and Suitability of ICL for Correction of Refractive Errors Without the Use of Dispersive OVDs

NCT06371079 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 448

Last updated 2024-11-25

Study results available
· View outcomes & findings →

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.

Conditions

  • Refractive Errors
  • Myopia
  • Myopic Astigmatism
  • Hypermetropia

Interventions

DEVICE

phakic intraocular lens implantation traditional

patients with refractive errors undergo surgical implantation of a lens inside the eye (implantable collamer lens or ICL) to correct these refractive errors. The procedure is done with help of use of both cohesive and dispersive OVD

DEVICE

phakic intraocular lens implantation reduced OVD

patients with refractive errors undergo surgical implantation of a lens inside the eye (implantable collamer lens or ICL) to correct these refractive errors. The procedure is done with help of use of only cohesive OVD without using dispersive OVD.

Sponsors & Collaborators

  • Loay Abdulmutalib Almusawi

    lead OTHER

Principal Investigators

  • Sohaib A Mahmood, FIBMS · Ibn Al-Haithem eye teaching hospital

  • Loay A Almusawi, FIBMS · University of Basrah

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2024-08-22
Completion
2024-08-22
FDA Device
Yes

Countries

  • Iraq

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06371079 on ClinicalTrials.gov