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Implantable Phakic Lens (IPCL) VS Implantable Collamer Lens

Primary Purpose

Myopia

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Implantable Collamer Lens (ICL) in treatment of myopia in adults.
Implantable Intraocular Lens (IPCL) in treatment of myopia in adults.
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tiba eye centerRecruiting
  • Al Masa eye centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

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

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

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Refractive outcome
Postoperative refractive error measured in spherical equivalent
Visual outcome
Uncorrected distance and near vision using Snellen's chart and using decimal fractions

Secondary Outcome Measures

Adverse reactions
adverse reactions will be recorded including intraocular inflammation, corneal endothelial changes and lens opactification

Full Information

First Posted
October 20, 2020
Last Updated
November 5, 2020
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04624035
Brief Title
Implantable Phakic Lens (IPCL) VS Implantable Collamer Lens
Official Title
Comparison Between Implantable Phakic Intraocular Lens and Implantable Collamer Lens in Treatment of Myopia in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 10, 2020 (Actual)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
October 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Implantable Collamer Lens (ICL, V4c with central hole) in treatment of myopia in adults.
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Acrylic Implantable Intraocular Lens (IPCL, V2) in treatment of myopia in adults
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Implantable Collamer Lens (ICL) in treatment of myopia in adults.
Other Intervention Name(s)
All drugs used were mentioned in the arm description
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Implantable Intraocular Lens (IPCL) in treatment of myopia in adults.
Other Intervention Name(s)
All drugs used were mentioned in the arm description
Intervention Description
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.
Primary Outcome Measure Information:
Title
Refractive outcome
Description
Postoperative refractive error measured in spherical equivalent
Time Frame
12 months
Title
Visual outcome
Description
Uncorrected distance and near vision using Snellen's chart and using decimal fractions
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Adverse reactions
Description
adverse reactions will be recorded including intraocular inflammation, corneal endothelial changes and lens opactification
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud F Rateb, MD
Phone
‭+20 100 8348480‬
Email
rateb@aun.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud F Rateb, MD
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tiba eye center
City
Asyut
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmoud Rateb, PhD
Facility Name
Al Masa eye center
City
Banhā
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed ElMohamady, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
18031820
Citation
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.
Results Reference
background
PubMed Identifier
22365084
Citation
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.
Results Reference
background
PubMed Identifier
17172886
Citation
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.
Results Reference
background
PubMed Identifier
19375059
Citation
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.
Results Reference
background
PubMed Identifier
15519075
Citation
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.
Results Reference
background
PubMed Identifier
28933042
Citation
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.
Results Reference
background
PubMed Identifier
21710954
Citation
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.
Results Reference
background
PubMed Identifier
30662257
Citation
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.
Results Reference
background
PubMed Identifier
26949611
Citation
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.
Results Reference
background
PubMed Identifier
35388352
Citation
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.
Results Reference
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Implantable Phakic Lens (IPCL) VS Implantable Collamer Lens

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