Implantable Phakic Lens (IPCL) VS Implantable Collamer Lens

Not Applicable

• Conditions: Myopia
• Interventions: Procedure: Implantable Collamer Lens (ICL) in treatment of myopia in adults.; Procedure: Implantable Intraocular Lens (IPCL) in treatment of myopia in adults.

• Registration Number: NCT04624035
• Lead Sponsor: Assiut University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-10
• Study Start: 2020-10-10
• Study First Submitted: 2020-10-20
• Study First Submitted QC: 2020-11-05
• Last Update Submitted: 2020-11-05
• Study First Posted: 2020-11-10
• Last Update Posted: 2020-11-10
• Primary Completion: 2021-01
• Study Completion: 2021-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Implantable Collamer Lens (ICL, V4c with central hole) in treatment of myopia in adults.	Implantable Collamer Lens (ICL) 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.
Acrylic Implantable Intraocular Lens (IPCL, V2) in treatment of myopia in adults	Implantable Intraocular Lens (IPCL) 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.

Primary Outcome Measures

Name	Time	Method
Visual outcome	12 months	Uncorrected distance and near vision using Snellen's chart and using decimal fractions
Refractive outcome	12 months	Postoperative refractive error measured in spherical equivalent

Secondary Outcome Measures

Name	Time	Method
Adverse reactions	12 months	adverse reactions will be recorded including intraocular inflammation, corneal endothelial changes and lens opactification

Trial Locations

Locations (2)

Al Masa eye center; 🇪🇬 Banhā, Egypt

Tiba eye center; 🇪🇬 Asyut, Egypt