Implantable Phakic Lens (IPCL) VS Implantable Collamer Lens

Assiut University

Status: Unknown

Conditions: Myopia

Treatments: Procedure: Implantable Intraocular Lens (IPCL) in treatment of myopia in adults.; Procedure: Implantable Collamer Lens (ICL) in treatment of myopia in adults.

Study type: Interventional

Funder types: Other

Identifiers

NCT04624035

ICL vs IPCL

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

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

Active Comparator group

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.

Treatment:

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 group

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.

Treatment:

Procedure: Implantable Intraocular Lens (IPCL) in treatment of myopia in adults.