AlAhmady Hamad AlSammans*, Ashraf Mostafa Moahammed and Usama Ali Mohammed
Department of Ophthalmology, Faculty of Medicine, Sohag University, Egypt
Received: 01 November, 2016; Accepted: 09 November, 2016; Published: 15 November, 2016
Alahmady Hamad Alsmman, MD, Department of Ophthalmology, Faculty of Medicine, Sohag University, 82524, Sohag, Egypt, Tel: 0020-11 11 10 26 98 ; E-mail:
AlSamman AH, Moahammed AM, Mohammed UA (2016) Anterior Chamber Foldable Phakic Intra Ocular Lens Safety and Efficacy. J Clin Res Ophthalmol 3(1): 011-017. 10.17352/2455-1414.000033
© 2016 AlSamman AH. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Phakic IOL; Myopia; Refractive surgery
PIOL: Phakic Intra Ocular Lens; IOL: intraocular Lens; LASIK: Laser Insitu Keratomeleiosis; PRK: Photorefracive Keratectomy; BCVA: Best Corrected Visual Acuity; UCVA: Uncorrected Visual Acuity; PMMA: Poly Methel Metha Arylate; ACD: Anterior Chamber Depth; ECD: Endothelial Cell Count; SE: Spherical Equivilant
Purpose: Correction of myopia by implantation of intra ocular lens is a growing surgery. In this study I am trying to assess the visual outcome stability and safety of eyes undergoing Anterior chamber foldable phakic lens implantation (Artiflex) (Ophtec BV, Groningen, The Netherlands) or (veriflex) (AMO,Santa Ana,CA) for myopia unsuitable for LASIK and detection of early and late complications along three years follow up period.
Methods: A retrospective analysis of 25 eyes of 16 patients underwent Anterior chamber foldable phakic IOL (Artiflex) or (Veriflex) implantation for correction of myopia all patients were unsuitable for LASIK all patients underwent surgery with one surgeon in same circumstances. Uncorrected visual acuity, corrected visual acuity (BCVA), higher-order aberrations, patient satisfaction, central endothelial cell count, and PIOL position centration and incarcerated iris tissue were determined along follow up period.
Results: At the end of the 36 months of follow up period 14 of the 25 eyes (56 %) achieved BCVA better than that measured pre-operatively and 10 of the 25 eyes (40%) matched their pre-operative BCVA. One eye (4 %) attained a final BCVA worse than pre-operatively, due to recurrent uveitis. One patient (4%) need another surgery to fixate the lens due to slippage of incarcerated iris tissue with impending displacement.
Conclusions: This study suggests that Anterior chamber foldable phakic IOL (iris claw lens insertion) Artiflex or Veriflex is beneficial in myopia, unsuitable for LASIK, matching or exceeding pre-operative BCVA in the overwhelming majority of the cases. With no major complications however long standing follow up is needed to avoid major complications.
Most of patients are hoping to see well without spectacle or contact lenses. So in last years the refractive surgery increased in patients dissatisfied with spectacles and contact lenses either due to quality of vision, cosmetic appearance or difficulties in contact lenses wearing and its complications. corneal surgeries like corneal ablation ( photorefractive keratectomy (PRK) and laser-assisted in situ keratomileusis LASIK) and different types of phakic intraocular lens (PIOL) implantation either in the anterior or posterior chamber and the anterior chamber either iris claw or angle fixation IOL aim to correct s refractive errors in myopic patients [1,2].
Corneal surgeries, such as photorefractive keratectomy (PRK) and LASIK, have many limitations and contraindications especially for the correction of high refractive errors. Postoperative ectasia which is a major problem can occur with removing of too much corneal tissue to correct high myopia with the laser. Night bad quality vision and dry eye complaints may be transient or permanent symptoms which may cause dissatisfaction for refractive patients. Due to these limitations and complications, indications for corneal refractive surgery have narrowed [3-6].
As many patients with myopia unsuitable for LASIK the Intraocular refractive procedures may be a good alternative: high degrees of ametropia thin corneas and keratoconus suspect can be corrected, more stable refraction, better visual quality in day and night and lastly reversibility of our technique all of above make intraocular refractive surgery is a good alternative in patients refusing glasses and contact lenses [7,8].
Intraocular refractive surgeries may be classified into: phakic intraocular lens (PIOL) implantation with preservation of crystalline lens and clear lens extraction with lens implantation, also called refractive lens exchange. Clear lens extraction may increases the risk for retinal detachment and is generally not preferable in myopic pre-presbyopic patients who can still accommodate as it deprive them from useful accommodation and always patient suffers from disability of near vision without glasses. Retinal detachment after refractive lens exchange for high myopia is always present and has been described to occur in 2% to 8% of patients which increase if complications occurred during surgery [9,10].
PIOL implantation in suitable patients may be more favorable than other refractive surgery techniques, the PIOL is potentially reversible as the PIOL is removable surgically with any major complication. Visual recovery is fast, and accommodation is preserved with great benefit in pre presbyopic patients. Implantation of a PIOL utilizes operative techniques familiar to most anterior segment surgeons and does not require expensive or specialised devices, such as an excimer laser. On the other hand complications relating to PIOLs can be more disabling than those from keratorefractive surgery. Glaucoma, cataract formation, corneal decompensation, uveitis, and endophthalmitis are potential complications after PIOL insertion .
In the 1980s, as an increasing number of reports indicated complications from use of the angle-supported PIOLs, a new type of anterior-chamber PIOL was developed based on the 1977 design of Jan Worst’s iris-fixated “iris-claw” lens [12-14].
The name of the PIOL was changed to Artisan (Ophtec BV, Groningen, The Netherlands), and it is available for myopic patients with powers from −3 to −23.5 D. In 2004, the PIOL gained FDA approval under the name Verisyse Phakic IOL (Abbott Medical Optics, Inc., Santa Ana, CA), with available powers from −5 to −20 D. A toric Artisan model is also available in Europe with parameters similar to the Artisan, but with cylindrical powers up to -7.5D [15-17].
The Artiflex and Veriflex foldable IOLs are a three-piece lenses were developed based on the Artisan design, with a flexible, 6.0-mm convex–concave silicone optic, PMMA haptics, and overall diameter of 8.5 mm.
Myopic IOL is available in powers of −2 to −14.5 D, and it utilizes a small (3.2 mm), self-sealing incision, thereby allowing for more rapid recovery of visual acuity. The Artiflex has Conformité Européene marking in the European Union and is undergoing FDA clinical trials as the Veriflex lens (Abbott Medical Optics, Inc.) .
Aim of the work
To assess the visual outcome stability and safety of eyes undergoing anterior chamber foldable phakic lens implantation (Artiflex and veriflex) for myopia unsuitable for LASIK and detection of early and late complications along three years follow up period.
Materials and Methods
In this study Helsinki guidelines were followed.
Twenty five eyes of 16 patients included in this study. Artiflex or Veriflex PIOL for correction of myopia was implanted in patients unsuitable for LASIK due to thin cornea, abnormal pentacam or refraction out of range of correction.This study were done between March 2010 and March 2012 , in a retrospective study. Inclusion criteria were patient age above 18years up to 40 years, in patients from 18 to 25 years stability of refraction for 6 months was mandatory, mesopic pupil size equal to or less than 6.5 mm, an anterior chamber depth (ACD) equal to or more than 2.85 mm, endothelial cell count more than 2000 cells/mm2, no history of previous ocular pathology like iritis, glaucoma, retinal detachment, retinal tear nor hole. No history of any intra ocular surgery including previous refractive corneal surgery. A written informed consent was obtained from all patients after full details about the procedure, its advantages and disadvantages and suggested complications. The study was done in Ophthalmology department Sohag Faculty of Medicine Sohag Egypt.
Patients were examined before the surgery, including uncorrected visual acuity (UCVA), best-spectacle corrected visual acuity (BSCVA),) refraction both manifest andand after complete cycloplegia by cyclopentolate 1% 6 hours before examination and the spherical equivalent (SE) were calculated, meticulus slit-lamp examination for the anterior segment , pupil size by manualcard comparison method was measured, corneal topography endothelial cell density (ECD), applanation tonomety by tonopen and fundus examination by direct and indirect ophthalmoscopy for detection of peripheral retinal abnormalities . UCVA and BSCVA were measured in decimal Snellen and converted to the logarithm of the minimum angle of resolution (logMAR). Corneal endothelium count was evaluated by use of Topcon noncontact specular microscope.
The calculation of the IOL power was done by using van der Heijde formula, which uses the corneal curvature, ACD, and manifest SE of the refractive error at a vertex distance of 12 mm, the calculation was done in each cases by the manufacturing company.
Before the surgery by one hour, topical antibiotic Vigamox (moxifloxacin hydrochloride ophthalmic solution 0.5%) with pilocarpine 2% (isoptocarpine) was installed in the conjunctival sac of all eyes every 15 minutes 4 times the miotics installed in order to ease lens fixation in the iris tissue and avoid pupil dilation after anaesthesia and protection of crystalline lens from touch during implantation. Surgeries were performed by same surgeon and under same circumstances all surgeries were done under general anaesthesia only 3mm clear corneal incision was performed at 12 o’clock by keratome ,the anterior chamber reformation by viscoelastic material (Healon GV, Abbott Medical Optics, Santa Ana, CA, USA) and two paracentesis were located at 10 o’clock and 2 o’clock. The PIOL was loaded on special spatula (Operaid Artiflex Implantation Spatula, Ophtec, Groningen, and the Netherlands) and introduced into the anterior chamber through keratome opening the lens after introduction it will be in vertical position from 12 to 6 o’clock there after rotated 90° into a horizontal position from 3 o’clock to 9 o’clock.
Fixation of the PIOL to the iris was done by catching the PMMA haptic by special curved forceps as the optic is foldable and any hold to the optic of no value. the iris tissue was enclavated into the haptics with the aid of Operaid Artiflex Enclavation Needle or simply be insulin needle after curving its tip 90 degree introduced from side pore for the right haptics and then repeated for the left one . A peripheral iridectomy was done surgically at 12 o’clock and the viscoelastic material was washed out with balanced solution. Hydration of the edges of the wound was done the wound usually is water tight and need no sutures however safety suture was placed to prevent wound leakage if needed. Postoperative drugs including Vigamox (moxifloxacin hydrochloride ophthalmic solution 0.5% Alcon) and prednisolon acetate( Pred forte Allergan) four times per day the first for one week and the second for one month and gradually withdrawn acetazolamide 250mg orally (cidamex Tablets )twice daily for three days only (Figures 1-3).