Long-term outcomes of intrastromal femtosecond laser presbyopia correction: 3-year results.

BACKGROUND/AIMS: To analyse visual outcomes and corneal changes 3 years after intrastromal femtosecond laser presbyopia treatment. METHODS: In a prospective, unicentric clinical trial, 25 presbyopic patients received INTRACOR treatment (Technolas femtosecond laser) on their non-dominant eye. Examinations were performed preoperatively as well as 1, 24 and 36 months postoperatively and included refraction, near, intermediate and distance visual acuity tests, reading speed, corneal topography, stray light measurement, endothelial cell count and slit-lamp examination. RESULTS: Comparison of preoperative versus 36 months postoperative values showed in median an improvement of uncorrected near visual acuity (UNVA) from 0.70 logMAR to 0.10 logMAR (p<0.001). Corrected distance visual acuity (CDVA) was reduced from -0.10 logMAR to 0.00 logMAR (p<0.001). The spherical equivalent preoperatively was 0.625 D and after an initial myopic shift after 1 month (0.125 D) and 24 months (0.25 D), the 36 months value (0.50 D) returned to resemble the preoperative value in statistical terms (p=0.123). A significant corneal steepening of 1.50 D in the treated area was measured. Pachymetry (thinnest point) revealed a statistically significant, but clinically insignificant corneal thickening from 535 to 549 µm (p=0.033). Endothelial cell count did not change. 92.86% of patients felt comfortable with the surgery result. CONCLUSION: INTRACOR treatment after 36 months improved UNVA to varying degrees. The effect can be explained by a corneal steepening. An initial myopic shift was reversible. Reductions especially in CDVA have to be taken into account and therefore careful patient selection and information is obligatory. TRIAL REGISTRATION NUMBER: NCT01164358 and NCT01025050, Results.

Intrastromal femtosecond laser surgical compensation of presbyopia with six intrastromal ring cuts: 3-year results.

BACKGROUND/AIMS: To assess over a 36-month period functional results of the modified INTRACOR femtosecond laser-based intrastromal procedure to treat presbyopia. METHODS: 20 eyes of 20 presbyopic patients with mild hyperopia were included. The INTRACOR procedure with a modified pattern (six concentric intrastromal ring cuts) was performed using the FEMTEC femtosecond laser (Bausch+Lomb/Technolas Perfect Vision, Munich, Germany). Patients were also randomly divided into three subgroups to compare the effect of three different small inner ring diameters (1.8/2.0/2.2 mm (Groups A/B/C)). Follow-up examinations were performed at 1, 3, 6, 12, 24 and 36 months, and included near and distance visual acuity tests, slit-lamp examinations and corneal topography. RESULTS: Median uncorrected near visual acuity (UNVA) increased from 0.7/0.7/0.7 logMAR (Groups A/B/C) to -0.1/0.1/0.1 logMAR 36 months after surgery. Uncorrected distance visual acuity changed slightly from 0.1/0.2/0.1 logMAR to 0.2/0.3/0.1 logMAR. Losses of two lines of binocular corrected distance visual acuity (CDVA) were noted in 0/25/0% of eyes. Median spherical equivalent changed from 0.75/0.75/0.75 dioptres to -0.19/0.13/-0.19 dioptres. Overall patient satisfaction with the procedure was 80%. CONCLUSIONS: INTRACOR with a modified pattern improved UNVA in all patients over a 36-month follow-up period. The possibility of reduced CDVA underlines the need for careful patient selection. TRIAL REGISTRATION NUMBER: NCT00928122.

Femtosecond laser correction of presbyopia (INTRACOR) in emmetropes using a modified pattern.

PURPOSE: To evaluate functional results and corneal changes after femtosecond laser correction of presbyopia (INTRACOR, Technolas Perfect Vision GmbH) in emmetropes using a modified treatment pattern over a 12-month period. METHODS: Twenty eyes from 20 emmetropic patients were treated with a modified intrastromal INTRACOR pattern consisting of 5 central rings and 8 radial cuts in a prospective, nonrandomized, uncontrolled, open, single-center, clinical study. Refraction, visual acuity, endothelial cell density, corneal pachymetry, total corneal power, and stray light were evaluated preoperatively and 1 (except endothelial cell density and stray light), 3, 6, and 12 months postoperatively. Patients filled out a subjective questionnaire at 12 months postoperatively. RESULTS: Comparison of preoperative versus 12-month postoperative median values revealed a significant improvement in uncorrected near visual acuity (UNVA) from 0.60 (20/80) to 0.10 logMAR (20/25) (P<.0001) and a significant decrease in corrected distance visual acuity (CDVA) from -0.10 (20/16) to 0.00 logMAR (20/20), which equals a median loss of one line (P=.0005). Fifteen percent of patients lost two lines of CDVA in the treated eye. Subjective spherical equivalent refraction remained unchanged at 0.00 diopters (D) (P=.194). After INTRACOR treatment, significant corneal steepening of 1.40 D and midperipheral flattening of 0.50 D occurred (both P<.0001). Corneal pachymetry at the thinnest point and endothelial cell density did not change significantly (P=.829 and P=.058, respectively). CONCLUSIONS: After 12 months, the modified INTRACOR pattern improved UNVA in emmetropic patients without inducing a myopic shift or significant changes in endothelial cell density or pachymetry.

Bilateral implantation of toric multifocal additive intraocular lenses in pseudophakic eyes.

UNLABELLED: A 41-year-old patient presented with hyperopia, astigmatism, and presbyopia for refractive treatment 6 years following cataract surgery. A toric multifocal additive intraocular lens with a near addition of +3.5 diopters (D) for sulcus implantation was chosen and implanted uneventfully. Follow-up examinations were performed from the first day until 9 months after surgery. A predictable refractive correction was seen, with a residual error of +0.125 D (spherical equivalent) in the right eye and emmetropia in the left eye. Monocular uncorrected distance visual acuity (UDVA) and uncorrected near visual acuity (UNVA) (40 cm) improved to 0.1 logMAR. It could not be improved further with near-add spectacles. Binocular UDVA and UNVA were 0.0 logMAR and 0.1 logMAR (80 cm), respectively. Both additive IOLs remained centered and on axis during the follow-up period. Spectacle independence was achieved, as was high patient satisfaction. FINANCIAL DISCLOSURE: The International Vision Correction Research Centre received research grants related to this publication from the following companies: Dr. Schmidt Intraocularlinsen GmbH, Rayner Intraocular Lenses, Ltd., and Carl Zeiss Meditec AG. No author has a financial or proprietary interest in any material or method mentioned.

Cataract surgery after previous femtosecond laser intrastromal presbyopia treatment.

UNLABELLED: We present a 58-year-old man who had cataract surgery in his right eye 8 months after femtosecond laser intrastromal presbyopia treatment (Intracor). The intraocular lens (IOL) power was calculated using the standard optical biometry data and the Holladay I formula without adjusting factors. Routine cataract removal was performed without complications followed by implantation of a monofocal IOL. The achieved spherical equivalent postoperatively was +0.25 diopters (D), which was +0.26 D different than the target refraction of the Holladay 1 formula. In conclusion, the IOL power calculation was predictable and the effect of the femtosecond intrastromal presbyopia treatment remained stable and improved further after cataract surgery: The pre-treatment uncorrected near visual acuity of 20/125 improved to 20/40 after treatment and to 20/25 six months after cataract surgery. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned.

Visual outcomes and corneal changes after intrastromal femtosecond laser correction of presbyopia.

PURPOSE: To assess the effect of intrastromal femtosecond laser presbyopia treatment on uncorrected near visual acuity (UNVA) and corneal integrity over an 18-month period. SETTING: Department of Ophthalmology, International Vision Correction Research Centre, University of Heidelberg, Heidelberg, Germany. DESIGN: Clinical trial. METHODS: The UNVA (at 40 cm), corneal pachymetry, and true net power were evaluated preoperatively and 1, 3, 6, 12, and 18 months after femtosecond intrastromal presbyopic treatment (Intracor). Endothelial cell density (ECD) was measured preoperatively and 3, 6, and 12 months postoperatively. Data were analyzed with the Wilcoxon test at a P=.01 level of significance. RESULTS: The median UNVA improved significantly from 0.7 logMAR preoperatively to 0.4 logMAR, 0.2 logMAR, 0.2 logMAR, 0.3 logMAR, and 0.2 logMAR at 1, 3, 6, 12, and 18 months, respectively (all P<.001). The median corneal true net power increased significantly by 1.1 diopters (D) to 0.7 D, 0.8 D, 1.0 D, and 0.9 D, respectively (all P<.001); pachymetry showed no significant thinning postoperatively. There was no significant difference in ECD between preoperatively and postoperatively. CONCLUSIONS: Intrastromal femtosecond presbyopic treatment yielded a significant and stable gain of UNVA and corneal steepening without significant loss of endothelial cells or corneal thinning up to 18 months postoperatively. No significant regression of visual acuity or further corneal steepening occurred during the follow-up period. FINANCIAL DISCLOSURE: Dr. Auffarth and Dr. Holzer received lecture and consulting fees from Technolas Perfect Vision GmbH. No author has a financial or proprietary interest in any material or method mentioned.