Myopia
Conditions
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.
Interventions
PROCEDUREImplantable 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.
PROCEDUREImplantable 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.
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Refractive outcome | 12 months | Postoperative refractive error measured in spherical equivalent |
| Visual outcome | 12 months | Uncorrected distance and near vision using Snellen's chart and using decimal fractions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse reactions | 12 months | adverse reactions will be recorded including intraocular inflammation, corneal endothelial changes and lens opactification |
Countries
Egypt
Contacts
Primary ContactMahmoud F Rateb, MD
Outcome results
None listed