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BACKGROUND AND OBJECTIVE: To report the correlation of central macular thickness (CMT) and best-corrected visual acuity (BCVA) after 1-year treatment by two doses (2.5 mg or 1.25 mg) of intravitreal ziv-aflibercept (IVZ) versus bevacizumab (IVB) in eyes with diabetic macular edema (DME). PATIENTS AND METHODS: In this study, the correlation of CMT and BCVA changes of the eyes enrolled in a previous clinical trial of 123 eyes were re-evaluated. The correlation of BCVA and CMT changes at each visit was evaluated in the three study arms individually. Then, the eyes in each of the arms were classified at each follow-up visit into three subgroups based on their CMT changes related to the baseline CMT: CMT decrease of 30% or more of baseline CMT, between 10% to 29% of baseline CMT, and less than 9% of baseline CMT or CMT increase. RESULTS: BCVA and CMT changes were correlated significantly (P < .05) in all and in half of the follow-up visits, respectively, in the eyes treated by IVZ 1.25 mg and IVB (r = 0.554 and r = 0.617 at 1 year, respectively). Nevertheless, such a significant correlation was not detected in the eyes treated by IVZ 2.5 mg in any of the follow-up visits (r = 0.202 at 1 year; P = .259). In the IVZ 2.5 mg group, BCVA improvement was observed in all subgroups with each level of CMT reductions. CONCLUSION: Ziv-aflibercept 2.5 mg might have a beneficial effect on DME beyond thickness reduction. [Ophthalmic Surg Lasers Imaging Retina. 2019;50:684-690.].

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PURPOSE: To report 1-year findings of a trial comparing 2 doses of intravitreal ziv-aflibercept (IVZ) with intravitreal bevacizumab (IVB) for treatment of center-involving diabetic macular edema (DME). DESIGN: Three-armed double-blind randomized clinical trial. PARTICIPANTS: A total of 123 eyes with center-involving DME. METHODS: In this clinical trial, eyes with DME were randomly assigned to 2.5 mg intravitreal ziv-aflibercept (42 eyes), 1.25 mg intravitreal ziv-aflibercept (42 eyes), and 1.25 mg IVB injections (39 eyes), every 4 weeks for 3 loading injections and then every 4 weeks for IVB and every 8 weeks for ziv-aflibercept injections. The patients were followed up to 1 year with complete ophthalmologic examination and central macular thickness (CMT) measurement by optical coherence tomography. MAIN OUTCOME MEASURES: Change in best-corrected visual acuity (BCVA) at 1 year. RESULTS: Although no significant difference was evident between the 2 ziv-aflibercept groups at 1 year, BCVA change was significantly better in both ziv-aflibercept groups (-0.33±0.26 and -0.38±0.34 logarithm of the minimum angle of resolution (logMAR) equal to 16 and 18 Early Treatment Diabetic Retinopathy Study (ETDRS) letters, for IVZ 2.5 and 1.25 mg, respectively) than in the IVB group (-0.26±0.35 logMAR, equal to 14 ETDRS letters) at final follow-up (P = 0.007 for IVZ 2.5 mg and P = 0.029 for IVZ 1.25 mg). Regarding CMT changes, there was no significant difference between the 2 ziv-aflibercept groups; however, a significantly greater reduction in CMT was observed in the ziv-aflibercept 2.5 mg group in comparison to the IVB group at 1 year (P = 0.029). Subgroup analysis disclosed no difference in BCVA outcomes at 1 year among the eyes with baseline BCVA >20/50. In the eyes with baseline BCVA ≤20/50, however, the improvement was significantly better at 1 year in both ziv-aflibercept groups compared with the IVB group (P = 0.002 for IVZ 2.5 mg and P = 0.001 for IVZ 1.25 mg). CONCLUSIONS: The 1-year results of this trial disclosed more vision improvement with IVZ compared with IVB in the treatment of center-involving DME. This stronger effect of IVZ, however, was detected in the eyes with initial worse level of vision (≤20/50).

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PURPOSE: To compare the efficacy of 2 doses of intravitreal ziv-aflibercept (IVZ) with intravitreal bevacizumab (IVB) in the treatment of center-involved diabetic macular edema (DME) at 12 weeks. DESIGN: Three-armed, double-blind, randomized clinical trial. PARTICIPANTS: Eyes with center-involved DME. METHODS: In this trial, 123 eyes with DME were randomly assigned to 3 injections of 1.25 mg IVZ, 2.5 mg IVZ, and 1.25 mg IVB every 4 weeks. Complete ophthalmologic examination and central macular thickness (CMT) measurement by optical coherence tomography were performed every 4 weeks up to 12 weeks. MAIN OUTCOME MEASURES: Change in best-corrected visual acuity (BCVA) at 12 weeks. RESULTS: Although no significant difference was evident between the 2 ziv-aflibercept groups at 12 weeks, the BCVA change was significantly better in the ziv-aflibercept 1.25 mg group than in the IVB group at the 12-week visit (P = 0.021). In regard to CMT changes, there was no significant difference between the 2 ziv-aflibercept groups; however, a significantly greater reduction in CMT was observed in the ziv-aflibercept 2.5 mg group compared with the IVB group at 12 weeks (P = 0.037). Subgroup analysis disclosed no difference in BCVA outcomes at 12 weeks among the groups in the eyes with baseline BCVA ≥20/50. In the eyes with baseline BCVA <20/50, the improvement was significantly better at 12 weeks in the ziv-aflibercept 1.25 mg group compared with the IVB group (P = 0.011). CONCLUSIONS: The 12-week results of this trial disclosed that both 1.25 mg and 2.5 mg doses of IVZ and IVB demonstrated BCVA improvement over baseline in the treatment of center-involved DME. However, a stronger effect of IVZ compared with IVB in terms of both visual acuity improvement and macular thickness reduction was detected in the eyes with initial BCVA <20/50. Longer-term efficacy and safety data will be needed to understand the role for this drug in practice.

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PURPOSE: To compare spherical aberration and contrast sensitivity function following implantation of four different foldable posterior chamber intraocular lenses (IOLs), namely Sensar, Akreos AO, Tecnis, and AcrySof IQ. METHODS: In this randomized clinical trial, 68 eyes of 68 patients with senile cataracts underwent phacoemulsification and IOL implantation with Sensar (n=17), Akreos AO (n=17), Tecnis (n=17), or AcrySof IQ (n=17). Uncorrected visual acuity (UCVA) and best spectacle-corrected visual acuity (BSCVA), spherical aberration and contrast sensitivity function (CSF) were compared among the study groups, 3 months after surgery. RESULTS: There was no significant difference between the study groups in terms of age (P = 0.21). Mean postoperative BSCVA with Sensar, Akreos AO, Tecnis, and AcrySof IQ was 0.15±0.10, 0.12±0.9, 0.08±0.08, and 0.08±0.07 logMAR, respectively (P=0.08). Spherical aberration measured over a 4 mm pupil was significantly higher with Sensar and Akreos AO than the two other IOLs. The difference between Tecnis and AcrySof IQ was significantly in favor of the former IOL. Over a 6 mm pupil, spherical aberrations were comparable with Sensar and Akreos AO, furthermore spherical aberration was also comparable among eyes implanted with Akreos AO, AcrySof IQ, and Tecnis. Sensar yielded significantly inferior results as compared to Acrysof IQ and Tecnis. CSF with Sensar was inferior to the three aspheric IOLs at the majority of spatial frequencies. Tecnis yielded significantly better mesopic CSF at 1.5 and 3 cycles per degree spatial frequencies. CONCLUSION: Tecnis and AcrySof IQ provided significantly better visual function as compared to Sensar and Akreos AO, especially with smaller pupil size. However, this difference diminished with increasing pupil size.

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PURPOSE: TO COMPARE SPHERICAL ABERRATION AND CONTRAST SENSITIVITY WITH TWO DIFFERENT TYPES OF ASPHERIC POSTERIOR CHAMBER INTRAOCULAR LENSES (PCIOLS): Tecnis Z9000 versus Akreos AO. METHODS: Thirty-four eyes of 34 patients undergoing phacoemulsification for senile cataracts were randomly assigned to implantation of Tecnis Z9000 or Akreos AO PCIOLs. Outcome measures included best-corrected visual acuity (BCVA), spherical aberration (SA) with 4 and 6 mm pupil diameters and contrast sensitivity under photopic and mesopic conditions at spatial frequencies of 1, 2, 5, 10 and 20 cycles per degree (cpd) three months postoperatively. RESULTS: Mean BCVA was 0.08±0.08 logMAR in the Tecnis Z9000 group and 0.11±0.09 logMAR in the Akreos AO group (P=0.33). SA was less with Tecnis than Akreos AO with 4 and 6 mm pupil diameter (0.14±0.10 µm vs 0.28±0.09µm, P< 0.001 and 0.30±0.18µm vs 0.33±0.08 µm, P=0.4, respectively). Contrast sensitivity was significantly higher in the Tecnis Z9000 group at 1, 2, 5 and 10 cpd under photopic and at 1, 2 and 10 cpd under mesopic conditions. CONCLUSION: Tecnis Z9000 IOL seems to entail better visual outcomes in terms of spherical aberration and contrast sensitivity as compared to Akreos AO.