Implantable Phakic Lens (IPCL) VS Implantable Collamer Lens

November 5, 2020 updated by: Mahmoud F. Rateb, Assiut University

Comparison Between Implantable Phakic Intraocular Lens and Implantable Collamer Lens in Treatment of Myopia in Adults

Phakic intraocular lenses (pIOL) of different designs and materials have been used effectively instead of corneal refractive surgery in certain situations. The pIOL exhibits a number of advantages over corneal techniques as it is suitable for high myopes, with lower production of aberrations, and superior contrast sensitivity. Keeping the accommodation is its definite lead over refractive lens exchange. The Visian implantable collamer lens (ICL; Staar Surgical, Monrovia, CA), a posterior chamber pIOL, has been stated to be useful for the correction of high myopia. Nevertheless, as an intraocular procedure, it is associated with a risk of complications as probable injury to anterior segment, retinal detachment and endophthalmitis.

The Implantable Phakic Contact Lens (IPCL V2, Caregroup Sight Solutions, India) has been developed as an alternative for the ICL, at a noticeable financial advantage. Furthermore, the highestmyopic correction which is instantly accessible with ICL is -18.0 D. Meanwhile, IPCL can provide correction higher degrees up to -30.0 D.

Former researches have been made to assess the safety and efficiency of ICL implantation, to evaluate various devices for anterior segment imaging postoperatively and to identify changes in anterior segment after surgery. A recent study determined the safety of the IPCL over a minimum follow-up period of one year. In this work the investigators aimed to compare the refractive results and the adverse effects of the IPCL and the ICL in treatment of myopia in adults.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mahmoud F Rateb, MD
  • Phone Number: ‭+20 100 8348480‬
  • Email: rateb@aun.edu.eg

Study Locations

  • Egypt
      • Asyut, Egypt
        • Recruiting
        • Tiba Eye Center
        • Contact:
          • Mahmoud Rateb, PhD
      • Banhā, Egypt
        • Recruiting
        • Al Masa eye center
        • Contact:
          • Mohamed ElMohamady, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • myopia of more than 6 diopter
  • central anterior chamber depth more than 2.8 mm

Exclusion Criteria:

  • unstable refraction
  • any other ocular disease
  • any systemic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Implantable Collamer Lens (ICL, V4c with central hole) in treatment of myopia in adults.
Implantation of ICL (V4c with central hole) for treatment of myopia in adults using peribulbar anesthesia. Thirty minutes before surgery, cycloplegic and phenylephrine eye drops were applied. Five minutes before surgery, povidone-iodine 5% was applied. The anterior chamber was filled with sodium hyaluronate 1%, which was completely removed at the end of the surgery. The lens was inserted using the ICL injector. Tobramycin and dexamethasone 0.1% eye drops were used four times a day for 10 days, after which diclofenac sodium eye drops were started four times a day for 2 weeks.
Procedure: Implantable Collamer Lens (ICL) in treatment of myopia in adults.
ICL Group: After mydriatic eye drops and topical anesthesia instillation, a 3-mm temporal corneal incision was done. Viscoelastic material was injected in the anterior chamber (AC). An injector cartridge (STAAR Surgical) was used to insert the ICL V4c model with central hole). The four footplates of the ICL were positioned on the ciliary sulcus at the 180° axis. Viscoelastic material was entirely taken away.
Other Names:
  • All drugs used were mentioned in the arm description
Active Comparator: Acrylic Implantable Intraocular Lens (IPCL, V2) in treatment of myopia in adults
Implantation of IPCL for treatment of Myopia in adults using peribulbar anesthesia. Thirty minutes before surgery, cycloplegic and phenylephrine eye drops were applied. Five minutes before surgery, povidone-iodine 5% was applied. The anterior chamber was filled with sodium hyaluronate 1%, which was completely removed at the end of the surgery. The lens was inserted using the IPCL injector. Tobramycin and dexamethasone 0.1% eye drops were used four times a day for 10 days, after which diclofenac sodium eye drops were started four times a day for 2 weeks.
Procedure: Implantable Intraocular Lens (IPCL) in treatment of myopia in adults.
IPCL Group: Topical anesthetic and mydriatic agents were instilled before surgery. Using peripulbar anaesthesia, the IPCL (V2 model with central hole) was implanted into the AC through a 3 mm clear corneal incision after viscoelastic material injection. The footplates were subsequently tucked behind the iris, followed by a thorough viscoelastic removal.
Other Names:
  • All drugs used were mentioned in the arm description

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Refractive outcome
Time Frame: 12 months
Postoperative refractive error measured in spherical equivalent
12 months
Visual outcome
Time Frame: 12 months
Uncorrected distance and near vision using Snellen's chart and using decimal fractions
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse reactions
Time Frame: 12 months
adverse reactions will be recorded including intraocular inflammation, corneal endothelial changes and lens opactification
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Mahmoud F Rateb, MD, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2020

Primary Completion (Anticipated)

January 1, 2021

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

October 20, 2020

First Submitted That Met QC Criteria

November 5, 2020

First Posted (Actual)

November 10, 2020

Study Record Updates

Last Update Posted (Actual)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 5, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICL vs IPCL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All of the individual participant data that underline the results of this trial will be available once completion of the study after de-identification.

IPD Sharing Time Frame

beginning 9 month and ending 36 months after trial publication

IPD Sharing Access Criteria

for individual participant data meta-analysis

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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