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Telescopic IOL system improves vision in patients with cataract and dry AMD
A plus lens in the sulcus and a minus lens in the capsular bag provides a magnification index of 1.25 times.
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A novel dual IOL system improved near and distance vision in eyes with cataract and dry age-related macular degeneration, according to a study.
The study authors reported safety and efficacy data for the iolAMD (London Eye Hospital Pharma), which comprises two injectable hydrophobic acrylic IOLs.
“We can preoperatively demonstrate with a prismatic magnification lens where to place the visual axis after iolAMD implantation to create a new focus for visual perception away from the macular pathology,” Fritz H. Hengerer, MD, PhD, the corresponding author, told Ocular Surgery News. “The telescopic implant system is able to provide patients suffering from severe visual loss due to dry AMD with a restoration of visual function, and the patients from my study group were able to read thereafter.”
Fritz H. Hengerer
The study was published in the Journal of Refractive Surgery.
Dual optic system
IOL1 is a high-power plus lens (+63 D) implanted in the sulcus. The lens has a 5-mm hyper-aspheric optic that is slightly decentered on the plate haptic, with a diameter of 11.75 mm to 12 mm. The haptic is bent anteriorly to enhance the recommended distance of 2 mm between optics after implantation.
IOL2 is a high-power minus lens (–49 D) implanted in the capsular bag. It has a 4-mm optic and an overall length of 11 mm.
“The posterior lens placed in the capsular bag is a high-power minus lens, and the sulcus IOL is high-power hyperopic based on a plate haptic,” Hengerer said.
Both lenses have a refractive index of 1.525 and, combined, a remaining refractive power of 21 D. The A-constant is estimated at 119.4. Magnification is provided up to 1.25 times.
The lenses act as a telescope that magnifies the image and distributes the retinal image 3° apart from the fovea. IOL1 is intentionally decentered 0.85 mm to distribute the retinal image.
Both lenses can be injected with a standard soft tip cartridge and injector system through a standard 3-mm incision.
The iolAMD system received CE mark approval in 2014.
Patients and procedures
The prospective pilot study included three eyes of two patients diagnosed with cataract and dry AMD who underwent small-incision phacoemulsification with topical anesthesia. A two-step clear corneal incision was placed at the 12 o’clock position, and single-plane side-port incisions were placed at the 9 and 3 o’clock positions.
A continuous curvilinear capsulorrhexis with a targeted diameter of 5 mm was performed through the main incision.
“The regular surgical approach using standard phaco settings and incisions can be used in general,” Hengerer said.
The primary endpoints were manifest refraction, uncorrected and corrected distance visual acuity, uncorrected and corrected near visual acuity, predicted corrected near visual acuity, postoperative position of the lenses, and intraoperative and postoperative complications and adverse events.
The iolAMD simulator was used to determine postoperative lens orientation.
“Cataract density may affect preoperative simulation as the higher opacities underestimate the potential effect up to two lines,” Hengerer said.
Fundus and OCT images were used to examine the macula.
Results and conclusions
All eyes gained monocular reading vision at 1 week after surgery. One patient with monocular implantation experienced diplopia for distance vision.
Preoperative corrected distance visual acuity ranged from 20/800 to 20/125 and corrected near visual acuity was 20/800 or less.
At 2 months postoperatively, corrected distance visual acuity and corrected near visual acuity ranged from 20/25 to 20/40.
Uncorrected near visual acuity ranged from 20/25 to 20/200. Uncorrected distance visual acuity ranged from 20/32 to 20/60.
No intraoperative or postoperative complications or IOP increases were reported. Visual recovery was similar to that of regular cataract surgery with one IOL implanted in the capsular bag.
“Until now, 9 months follow-up time, there were no IOL-related complications to report. All patients are without ocular medication, and no rise in IOP could be detected. The pupils were not altered, and light reaction is regular,” Hengerer said. – by Matt Hasson
Reference:
Hengerer FH, et al. J Refractive Surg. 2015;doi:10.3928/1081597X-20150220-03.For more information:
Fritz H. Hengerer, MD, PhD, can be reached at Theodor-Stern-Kai 7, 60590 Frankfurt am Main, Germany; email: fritz.hengerer@kgu.de.Disclosure: Hengerer reports no relevant financial disclosures.
Perspective
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Jorge L. Alió, MD, PhD
This study reports the initial results of a new telescopic IOL in three patients. The purpose is to improve near vision in AMD by implanting a lens that has a double optic based on the Galileo optical system.
My experience with these telescopic devices is somewhat disappointing. Even though the patients can improve initially, we are dealing with a chronic disease that is progressive and usually leads to an incapacitating vision over time. Bearing this in mind, these devices provide good far vision with an adequate residual refraction and no limitations to the visual field and could be helpful for a while for these patients. The study is too short to make conclusions and should be considered as a feasibility study rather than a clinical study in which the opinion on this lens can be firmly stated.
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