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

NCT06371079 | Completed Results FDA Device

• 1 other identifier: NO-OVD-ICL
• Study Type: observational
• Target: 448
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

refractive errors; myopia; hypermetropia; astigmatism; refractive surgery; ICL; ophthalmic viscosurgical device

Outcome Measures

Primary Outcomes (1)

• Unaided Visual Acuity After the Procedure

  visual acuity (vision of the patient) without use of any glasses measured using LogMar charts. This measure has no specified units

  1-2 years after the surgery

Secondary Outcomes (4)

• Intraocular Pressure Postoperatively

  first day, first week and first month after the procedure

• Specular Microscopy Parameter: Endothelial Cell Density

  1-2 years after the surgery

• Specular Microscopy Parameter: Endothelial Cells Hexagonality

  1-2 years after the surgery

• Specular Microscopy Parameter: Coefficient of Variation of Corneal Endothelial Cells

  1-2 years after the surgery

Other Outcomes (1)

• Postoperative Complications

  any time post op within the maximum 2 years follow up period

Study Arms (2)

Traditional OVD group

In this group of patients, the ICL was implanted utilizing both cohesive and dispersive ophthalmic viscosurgical device.

Device: phakic intraocular lens implantation traditional

Reduced OVD group

In this group of patients, the ICL was implanted with the use of cohesive OVD only.

Device: phakic intraocular lens implantation reduced OVD

Interventions

phakic intraocular lens implantation traditional DEVICE

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

Also known as: ICL implantation traditional, Intraocular refractive surgery

Traditional OVD group

phakic intraocular lens implantation reduced OVD DEVICE

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.

Also known as: ICL implantation reduced OVD, Intraocular refractive surgery

Reduced OVD group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Records of patients that had undergone ICL implantation surgery in Al-Ferdows private eye hospital in Baghdad between 2017 and 2023 were accessed. Two groups of patients were identified, for the first group the ICL was implanted with the use of both dispersive and cohesive OVDs (traditional OVD group) and for the second one, a novel method of implantation was used without utilizing dispersive OVD (reduced OVD) group.

You may qualify if:

• 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.

You may not qualify if:

• patients with severe ocular surface disease, unstable refraction, glaucoma, cataract, retinal detachment and uveitis.

Sponsors & Collaborators

• Loay Abdulmutalib Almusawi: lead

Study Sites (1)

Al-Ferdows private eye hospital

Baghdad, Iraq

Location

Related Publications (3)

• Peng M, Tang Q, Zhao L, Khan MA, Lin D. Safety of implantable Collamer lens implantation without ophthalmic viscosurgical device: A retrospective cohort study. Medicine (Baltimore). 2020 Jun 12;99(24):e20691. doi: 10.1097/MD.0000000000020691.

  PMID: 32541520 BACKGROUND

• Zhang Z, Niu L, Zhao J, Miao H, Chen Z, Shen Y, Chen X, Ye Y, Wang X, Zhou X. Safety of EVO ICL Implantation With an Ophthalmic Viscosurgical Device-Free Technique in the Early 24 h After Surgery. Front Med (Lausanne). 2021 Nov 17;8:764653. doi: 10.3389/fmed.2021.764653. eCollection 2021.

  PMID: 34869472 BACKGROUND

• Qin Q, Bao L, He Z, Chen F, Zhu D, Zhang S, Zhang W, Liu Y, Gao R, Xie Z. Pure ICL Implantation: A Novel Ophthalmic Viscosurgical Device-Free Method. J Ophthalmol. 2021 Oct 6;2021:7363267. doi: 10.1155/2021/7363267. eCollection 2021.

  PMID: 34659826 BACKGROUND

MeSH Terms

Conditions

Refractive Errors; Myopia; Astigmatism; Hyperopia

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Loay Abdulmutalib Almusawi
• Organization: Basrah Medical College

loay.almusawi@uobasrah.edu.iq

009647705559205

Study Officials

• Sohaib A Mahmood, FIBMS

  Ibn Al-Haithem eye teaching hospital

  STUDY CHAIR

• Loay A Almusawi, FIBMS

  University of Basrah

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ophthalmology Lecturer

Study Record Dates

• First Submitted: April 6, 2024
• First Posted: April 17, 2024
• Study Start: March 1, 2024
• Primary Completion: August 22, 2024
• Study Completion: August 22, 2024
• Last Updated: November 25, 2024
• Results First Posted: November 25, 2024

Record last verified: 2024-11

Locations

IR (1)