NCT04624035

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2020

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

November 10, 2020

Status Verified

October 1, 2020

Enrollment Period

3 months

First QC Date

October 20, 2020

Last Update Submit

November 5, 2020

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

  • Refractive outcome

    Postoperative refractive error measured in spherical equivalent

    12 months

  • Visual outcome

    Uncorrected distance and near vision using Snellen's chart and using decimal fractions

    12 months

Secondary Outcomes (1)

  • Adverse reactions

    12 months

Study Arms (2)

Implantable Collamer Lens (ICL, V4c with central hole) in treatment of myopia in adults.

ACTIVE COMPARATOR

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.

Acrylic Implantable Intraocular Lens (IPCL, V2) in treatment of myopia in adults

ACTIVE COMPARATOR

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.

Interventions

Implantable Collamer Lens (ICL) in treatment of myopia in adults.PROCEDURE

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.

Also known as: All drugs used were mentioned in the arm description
Implantable Collamer Lens (ICL, V4c with central hole) in treatment of myopia in adults.
Implantable Intraocular Lens (IPCL) in treatment of myopia in adults.PROCEDURE

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.

Also known as: All drugs used were mentioned in the arm description
Acrylic Implantable Intraocular Lens (IPCL, V2) in treatment of myopia in adults

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tiba eye center

Asyut, Egypt

RECRUITING

Al Masa eye center

Banhā, Egypt

RECRUITING

Related Publications (10)

  • Stulting RD, John ME, Maloney RK, Assil KK, Arrowsmith PN, Thompson VM; U.S. Verisyse Study Group. Three-year results of Artisan/Verisyse phakic intraocular lens implantation. Results of the United States Food And Drug Administration clinical trial. Ophthalmology. 2008 Mar;115(3):464-472.e1. doi: 10.1016/j.ophtha.2007.08.039. Epub 2007 Nov 26.

    PMID: 18031820BACKGROUND

  • Kamiya K, Igarashi A, Shimizu K, Matsumura K, Komatsu M. Visual performance after posterior chamber phakic intraocular lens implantation and wavefront-guided laser in situ keratomileusis for low to moderate myopia. Am J Ophthalmol. 2012 Jun;153(6):1178-86.e1. doi: 10.1016/j.ajo.2011.12.005. Epub 2012 Feb 23.

    PMID: 22365084BACKGROUND

  • Sanders D, Vukich JA. Comparison of implantable collamer lens (ICL) and laser-assisted in situ keratomileusis (LASIK) for low myopia. Cornea. 2006 Dec;25(10):1139-46. doi: 10.1097/ICO.0b013e31802cbf3c.

    PMID: 17172886BACKGROUND

  • Igarashi A, Kamiya K, Shimizu K, Komatsu M. Visual performance after implantable collamer lens implantation and wavefront-guided laser in situ keratomileusis for high myopia. Am J Ophthalmol. 2009 Jul;148(1):164-70.e1. doi: 10.1016/j.ajo.2009.02.001. Epub 2009 Apr 17.

    PMID: 19375059BACKGROUND

  • Pineda-Fernandez A, Jaramillo J, Vargas J, Jaramillo M, Jaramillo J, Galindez A. Phakic posterior chamber intraocular lens for high myopia. J Cataract Refract Surg. 2004 Nov;30(11):2277-83. doi: 10.1016/j.jcrs.2004.03.035.

    PMID: 15519075BACKGROUND

  • Elmohamady MN, Abdelghaffar W. Anterior Chamber Changes After Implantable Collamer Lens Implantation in High Myopia Using Pentacam: A Prospective Study. Ophthalmol Ther. 2017 Dec;6(2):343-349. doi: 10.1007/s40123-017-0109-3. Epub 2017 Sep 20.

    PMID: 28933042BACKGROUND

  • Fernandes P, Gonzalez-Meijome JM, Madrid-Costa D, Ferrer-Blasco T, Jorge J, Montes-Mico R. Implantable collamer posterior chamber intraocular lenses: a review of potential complications. J Refract Surg. 2011 Oct;27(10):765-76. doi: 10.3928/1081597X-20110617-01. Epub 2011 Jun 30.

    PMID: 21710954BACKGROUND

  • Sachdev G, Ramamurthy D. Long-term safety of posterior chamber implantable phakic contact lens for the correction of myopia. Clin Ophthalmol. 2019 Jan 7;13:137-142. doi: 10.2147/OPTH.S185304. eCollection 2019.

    PMID: 30662257BACKGROUND

  • Zhang J, Luo HH, Zhuang J, Yu KM. Comparison of anterior section parameters using anterior segment optical coherence tomography and ultrasound biomicroscopy in myopic patients after ICL implantation. Int J Ophthalmol. 2016 Jan 18;9(1):58-62. doi: 10.18240/ijo.2016.01.10. eCollection 2016.

    PMID: 26949611BACKGROUND

  • Rateb M, Gad AAM, Tohamy D, Elmohamady MN. A Prospective Comparative Study between Implantable Phakic Intraocular Contact Lens and Implantable Collamer Lens in Treatment of Myopia in Adults. J Ophthalmol. 2022 Mar 28;2022:9212253. doi: 10.1155/2022/9212253. eCollection 2022.

    PMID: 35388352DERIVED

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Mahmoud F Rateb, MD

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahmoud F Rateb, MD

CONTACT

‭+20 100 8348480‬rateb@aun.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of ophthalmology

Study Record Dates

First Submitted

October 20, 2020

First Posted

November 10, 2020

Study Start

October 10, 2020

Primary Completion

January 1, 2021

Study Completion

October 1, 2021

Last Updated

November 10, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
beginning 9 month and ending 36 months after trial publication
Access Criteria
for individual participant data meta-analysis

Locations

EG(2)