One-year Outcome of Intravitreal Dexamethasone Implant for Diabetic Macular Edema Patients

No Hae Park; Hyun Duck Kwak; Chang Ki Yoon; Ji Eun Lee; Min Sagong; Sang Joon Lee; Joo Eun Lee; Kun Hyung Kim; Hyun Woong Kim

doi:10.3341/jkos.2019.60.2.135

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Park, Kwak, Yoon, Lee, Sagong, Lee, Lee, Kim, and Kim: One-year Outcome of Intravitreal Dexamethasone Implant for Diabetic Macular Edema Patients

Original Article

Journal of the Korean Ophthalmological Society 2019; 60(2): 135-143.

Published online: 15 February 2019

DOI: https://doi.org/10.3341/jkos.2019.60.2.135

One-year Outcome of Intravitreal Dexamethasone Implant for Diabetic Macular Edema Patients

No Hae Park, MD¹, Hyun Duck Kwak, MD¹, Chang Ki Yoon, MD¹, Ji Eun Lee, MD, PhD³, Min Sagong, MD, PhD⁴, Sang Joon Lee, MD, PhD⁵, Joo Eun Lee, MD, PhD⁶, Kun Hyung Kim, MD⁷, Hyun Woong Kim, MD, PhD²

¹Department of Ophthalmology, Busan Paik Hospital, Inje University College of Medicine, Busan, Korea.

²Department of Ophthalmology, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea.

³Department of Ophthalmology, Pusan National University School of Medicine, Yangsan, Korea.

⁴Department of Ophthalmology, Yeungnam University College of Medicine, Daegu, Korea.

⁵Department of Ophthalmology, Kosin University College of Medicine, Busan, Korea.

⁶Jea Seung Youn's Eyeclinic, Busan, Korea.

⁷Institute of Environmental and Occupational Medicine, Department of Occupational and Environmental Medicine, Inje University College of Medicine, Busan, Korea.

Address reprint requests to Hyun Woong Kim, MD, PhD. Department of Ophthalmology, Haeundae Paik Hospital, Inje University College of Medicine, #875 Haeundae-ro, Haeundae-gu, Busan 48108, Korea. Tel: 82-51-797-2310, Fax: 82-51-797-2030, maekbak@hanmail.net

Received 26 July 2018 Revised 2 October 2018 Accepted 24 January 2019

The Korean Ophthalmological Society

(open-access):

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Purpose

The 1-year outcomes of intravitreal dexamethasone implants in diabetic macular edema (DME) patients were evaluated.

Methods

The medical records of 67 patients (70 eyes) with DME were reviewed retrospectively. All patients were treated with intravitreal dexamethasone implants more than twice a year and followed up for at least 1 year from the first dexamethasone implant injection. The best-corrected visual acuity (BCVA), central macular thickness (CMT), and intraocular pressure (IOP) were measured at every visit after the first injection. Adverse effects, including cataract formation and elevation of IOP, were analyzed.

Results

The mean patient age was 58.72 ± 9.91 years and 38 patients were male. The average number of injections was 2.73 ± 0.65 and the interval between injections was 21.52 ± 8.47 weeks. The average baseline BCVA and CMT were 0.59 ± 0.30 logMAR and 457.17 ± 133.10 µm, respectively. The BCVA was significantly improved from 3 months after the first injection, but this result did not last for 1 year. The CMT was significantly decreased compared to baseline for 1 year (p < 0.001). Group analysis revealed that the BCVA improved significantly in the group with HbA1c < 8.1% compared to the group with HbA1c ≥ 8.1% (p = 0.044), and the CMT improved significantly in the group with absent subretinal fluid compared to the group with the presence of subretinal fluid (p = 0.009). An elevated IOP was observed in 18 eyes (24%), and cataract formation was observed in 10 eyes (14%).

Conclusions

Intravitreal dexamethasone implants resulted in visual acuity stabilization and macular edema reduction in patients with DME.

Keywords: Dexamethasone, Diabetes mellitus, Macular edema

Figures and Tables

Figure 1

BCVA and CMT results. (A) BCVA was significantly increased at 1, 3, 9 months after the first injection. (B) CMT was decreased at 1, 3, 6, 9, 12 months after the first injection. BCVA = best corrected visual acuity; logMAR = logarithm of the minimum angle of resolution; CMT = central macular thickness; mon = month(s). ^*p < 0.05, against baseline by paired t-test.

Figure 2

Mean changes in the intraocular pressure. Mean changes in the intraocular pressure was significantly increased at 1, 3, 6, 9, 12 months after the first injection. mon = month(s). ^*p < 0.05, against baseline by paired t-test.

Figure 3

Univariate analysis (by GEE) for BCVA and CMT change from baseline. (A) Pseudophakic eyes showed no significant difference in BCVA and CMT compared to phakic eyes. (B) Vitrectomized eyes showed no significant difference in BCVA but significantly large decrease in CMT compared to non-vitrectomized eyes. (C) Absence of SRF group showed no significant difference in BCVA but significantly large decrease in CMT compared to the presence of SRF group. (D) Focal DME eyes showed significant increase in BCVA but no difference in CMT compared to diffuse DME eyes. (E) HbA1c < 8.1% group showed significant improvement of BCVA as well as decrease of CMT compared to HbA1c ≥ 8.1% group. BCVA = best corrected visual acuity; logMAR = logarithm of the minimum angle of resolution; GEE = generalized estimating equation; mon = month(s); CMT = central macular thickness; SRF = subretinal fluid; DME = diabetic macular edema.

Table 1

Baseline characteristics of enrolled patients

Values are presented as mean ± standard deviation or n (%).

DM = diabetes mellitus; DME = diabetic macular edema; VEGF = vascular endothelial growth factor; BCVA = best corrected visual acuity; logMAR = logarithm of the minimum angle of resolution; CMT = central macular thickness; IOP = intraocular pressure; SRF = subretinal fluid.

Table 2

Adverse effects of ozurdex injection and results on the injection number and the interval during follow-up period

Values are presented as mean ± standard deviation or n (%).

IOP = intraocular pressure; VEGF = vascular endothelial growth factor.

Table 3

Multivariate analysis (by GEE) for BCVA change from baseline

GEE = generalized estimating equation; BCVA = best corrected visual acuity; B = beta coefficient; S.E. = standard error; CI = confidence interval; SRF = subretinal fluid; DME = diabetic macular edema.

^*Wald statistics of GEE.

Table 4

Multivariate analysis (by GEE) for CMT change from baseline

GEE = generalized estimating equation; CMT = central macular thickness; B = beta coefficient; S.E. = standard error; CI = confidence interval; SRF = subretinal fluid; DME = diabetic macular edema.

^*Wald statistics of GEE.

Notes

^{Conflicts of Interest} The authors have no conflicts to disclose.

References

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One-year Outcome of Intravitreal Dexamethasone Implant for Diabetic Macular Edema Patients

Abstract

Purpose

Methods

Results

Conclusions

Figures and Tables

Figure 1

Figure 2

Mean changes in the intraocular pressure. Mean changes in the intraocular pressure was significantly increased at 1, 3, 6, 9, 12 months after the first injection. mon = month(s). *p < 0.05, against baseline by paired t-test.

Figure 3

Table 1

Baseline characteristics of enrolled patients

Table 2

Adverse effects of ozurdex injection and results on the injection number and the interval during follow-up period

Table 3

Multivariate analysis (by GEE) for BCVA change from baseline

Table 4

Multivariate analysis (by GEE) for CMT change from baseline

Notes

References

Mean changes in the intraocular pressure. Mean changes in the intraocular pressure was significantly increased at 1, 3, 6, 9, 12 months after the first injection. mon = month(s). ^*p < 0.05, against baseline by paired t-test.