Clinical observation of subretinal injection of compound electrolyte intraocular irrigation solution in the treatment of diabetic macular edema with hard exudate_Chinese Journal of Ocular Fundus Diseases

Authors：

Li Jiangling ¹ , Chang Lu ² , Zhang Jie ¹ , Gao Rongyu ¹ , Dai Qing ¹ ,  Sun Xianyong ¹

1. Fundus Disease Department of Weifang Eye Hospital, Weifang 2610002, China;
2. Fundus Disease Departmentof Kunming Aier Eye Hospital, Kunming 650000, China;

Corresponding author：

Sun Xianyong, Email: xianyongs1968@aliyun.com

Keywords：

Hard exudate; Diabetic macular edema; Subretinal injection; Compound electrolyte intraocular irrigating solution; Conbercept

DOI：

10.3760/cma.j.cn511434-20230508-00200

Video：

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Objective To observe the clinical effect of vitrectomy, inner limiting membrane (ILM) peeling, subretinal injection of compound electrolyte intraocular irrigation solution (CEIIS) and conbercept in the treatment of diabetic macular edema (DME) with hard exudate (HE) (DME-HE). Methods A prospective clinical study. Thirty-three patients with DME-HE diagnosed by examination in Weifang Eye Hospital from June 2020 to February 2022 were included in the study. Among them, there were 15 males (16 eyes) and 18 females (20 eyes), with the mean age of (62.00±6.54) years. All patients underwent the examinations of best corrected visual acuity (BCVA), scanning laser ophthalmoscope, optical coherence tomography (OCT), and multifocal electroretinography (mf-ERG). Snellen visual acuity chart was used for BCVA examination, which was converted into logarithm of the minimum angle of resolution (logMAR) BCVA for statistic analysis. Macular foveal retinal thickness (CMT) and macular volume (MV) were measured by OCT. The 1 ring P1 wave amplitude density was measured by mf-ERG. The patients were randomly divided into group A and group B, with 17 patients (18 eyes) and 16 patients (18 eyes), respectively. There were no significant differences in age, logMAR BCVA, HE area, CMT, MV, and 1 ring P1 wave amplitude density between the two groups (t=0.403, 0.972, 0.291, 0.023, －0.268, －0.206; P＞0.05). Group A was treated with vitrectomy, ILM peeling, and subretinal injection of CEIIS and conbercept (combined therapy). Group B was treated with intravitreal injection of conbercept (IVC). Follow-up was 12 months after treatment. The changes of BCVA, HE area, CMT, MV, 1 ring P1 wave amplitude density were compared between groups and groups after treatment. The times of injection and complications after treatment were observed. Independent sample t test was used for comparison between the two groups. Results At 12 months after treatment, compared to before treatment, there were significant differences in logMAR BCVA (F=14.837), HE area (χ²=94.522), CMT (χ²=199.212), MV (χ²=81.914) and 1 ring P1 wave amplitude density (F=8.933) in group A (P＜0.05); there were significant differences in CMT (F=5.540) and MV (F=7.836) in group B (P＜0.05). Compared between the two groups, logMAR BCVA: 1 week and 6 and 12 months after treatment, the difference was statistically significant (t=2.231, －2.122, －3.196; P＜0.05); HE area: except 1 week after treatment, there were statistically significant differences at other times after treatment (t=－2.422, －3.107, －3.540, －4.119; P＜0.05). CMT, MV, 1 ring P1 wave amplitude density: 12 months after treatment, the differences were statistically significant (t=－2.653, －2.455, 2.204; P＜0.05). During the follow-up period, the injection times of group A and group B were (3.06±1.89) and (5.56±2.04), respectively, and the difference was statistically significant (t=－3.815, P＜0.05). Macular hole and vitreous hematoma were found in 1 eye in group A and 1 eye in group B. Conclusion Vitrectomy, ILM peeling, subretinal injection of CEIIS and conbercept to treat DME-HE can effectively remove HE, alleviate macular edema, improve BCVA, and reduce CMT and MV. Combination therapy can reduce the number of IVC re-treatments.

Citation： Li Jiangling, Chang Lu, Zhang Jie, Gao Rongyu, Dai Qing, Sun Xianyong. Clinical observation of subretinal injection of compound electrolyte intraocular irrigation solution in the treatment of diabetic macular edema with hard exudate. Chinese Journal of Ocular Fundus Diseases, 2023, 39(12): 979-985. doi: 10.3760/cma.j.cn511434-20230508-00200 Copy

1.	Kim EJ, Lin WV, Rodriguez SM, et al. Treatment of diabetic macular edema[J]. Curr Diab Rep, 2019, 19(9): 68. DOI: 10.1007/s11892-019-1188-4.
2.	Takagi H, Otani A, Kiryu J, et al. New surgical approach for removing massive foveal hard exudates in diabetic macular edema[J]. Ophthalmology, 1999, 106(2): 249-257. DOI: 10.1016/S0161-6420(99)90054-4.
3.	杨鑫. 糖尿病相关黄斑病变硬性渗出的危险因素及治疗[J]. 中华实验眼科杂志, 2014, 32(11): 1041-1046. DOI: 10.3760/cma.j.issn.2095-0160.2014.11.016.Yang X. Risk factors and management of diabetes-related macular hard exudates[J]. Chin J Exp Ophthalmol, 2014, 32(11): 1041-1046. DOI: 10.3760/cma.j.issn.2095-0160.2014.11.016.
4.	Lin HC, Yang CM, Chen SN, et al. Vitrectomy with internal limiting membrane peeling versus nonsurgical treatment for diabetic macular edema with massive hard exudates[J/OL]. PLoS One, 2020, 15(7): e0236867[2020-07-31]. https://europepmc.org/article/MED/32735583. DOI:10.1371/journal.pone.0236867.
5.	Shi R, Guo Z, Yang X, et al. Aggravation of retinal hard exudates after intravitreal anti-vascular endothelial growth factor therapy for cystoid macular edema and the risk factors: a retrospective study[J]. BMC Ophthalmol, 2022, 22(1): 92. DOI: 10.1186/s12886-022-02315-z.
6.	Kim HR, Yoon CK, Kim HW, et al. New method of quantitative analysis of hard exudate using optical coherence tomography: application in diabetic macular edema[J]. Korean J Ophthalmol, 2019, 33(5): 399-405. DOI: 10.3341/kjo.2019.0049.
7.	王晓东, 叶瑞珍, 吴晓玉. 多焦视网膜电图对单纯型糖尿病视网膜病变的评估分析[J]. 糖尿病新世界, 2022, 25(11): 5-8, 29. DOI: 10.16658/j.cnki.1672-4062.2022.11.005.Wang XD, Ye RZ, Wu XY. Evaluation and analysis of multifocal electroretinogram for simple diabetic retinopathy[J]. Diabetes New World, 2022, 25(11): 5-8, 29. DOI: 10.16658/j.cnki.1672-4062.2022.11.005.
8.	Holm K, Ponjavic V, Lövestam-Adrian M. Using multifocal electroretinography hard exudates affect macular function in eyes with diabetic retinopathy[J]. Graefe’s Arch Clin Exp Ophthalmol, 2010, 248(9): 1241-1247. DOI: 10.1007/s00417-010-1347-4.
9.	Chhablani J, Jhingan M, Goud A, et al. Macular edema resolution assessment with implantable dexamethasone in diabetic retinopathy (MERIT): a pilot study[J]. Clin Ophthalmol, 2018, 12: 1205-1211. DOI: 10.2147/OPTH.S163681.
10.	Chang YC, Wu WC. Dyslipidemia and diabetic retinopathy[J]. Rev Diabet Stud, 2013, 10(2-3): 121-132. DOI: 10.1900/RDS.2013.10.121.
11.	Everett LA, Paulus YM. Laser therapy in the treatment of diabetic retinopathy and diabetic macular edema[J]. Curr Diab Rep, 2021, 21(9): 35. DOI: 10.1007/s11892-021-01403-6.
12.	Srinivas S, Verma A, Nittala MG, et al. Effect of intravitreal ranibizumab on intraretinal hard exudates in eyes with diabetic macular edema[J]. Am J Ophthalmol, 2020, 211: 183-190. DOI: 10.1016/j.ajo.2019.11.014.
13.	Takaya K, Suzuki Y, Mizutani H, et al. Long-term results of vitrectomy for removal of submacular hard exudates in patients with diabetic maculopathy[J]. Retina, 2004, 24(1): 23-29. DOI: 10.1097/00006982-200402000-00004.
14.	Kumagai K, Ogino N, Fukami M, et al. Removal of foveal hard exudates by subretinal balanced salt solution injection using 38-gauge needle in diabetic patients[J]. Graefe’s Arch Clin Exp Ophthalmol, 2020, 258(9): 1893-1899. DOI: 10.1007/s00417-020-04756-y.
15.	Domalpally A, Ip MS, Ehrlich JS. Effects of intravitreal ranibizumab on retinal hard exudate in diabetic macular edema: findings from the RIDE and RISE phase Ⅲ clinical trials[J]. Ophthalmology, 2015, 122(4): 779-786. DOI: 10.1016/j.ophtha.2014.10.028.
16.	曾苗, 陈晓, 洪玲, 等. 视网膜下注射平衡盐溶液治疗难治性糖尿病黄斑水肿的初步报告[J]. 中华眼底病杂志, 2020, 36(6): 462-466. DOI: 10.3760/cma.j.cn511434-20190304-00065.Zeng M, Chen X, Hong L, et al. Subretinal injection of balanced salt solution for the resolution of refractory diabetic macular edema[J]. Chin J Ocul Fundus Dis, 2020, 36(6): 462-466. DOI: 10.3760/cma.j.cn511434-20190304-00065.
17.	Morizane Y, Kimura S, Hosokawa M, et al. Planned foveal detachment technique for the resolution of diffuse diabetic macular edema[J]. Jpn J Ophthalmol, 2015, 59(5): 279-287. DOI: 10.1007/s10384-015-0390-4.
18.	Michalewska Z, Stewart MW, Landers MB 3rd, et al. Vitrectomy in the management of diabetic macular edema in treatment-naïve patients[J]. Can J Ophthalmol, 2018, 53(4): 402-407. DOI: 10.1016/j.jcjo.2017.10.011.
19.	Dehghan MH, Salehipour M, Naghib J, et al. Pars plana vitrectomy with internal limiting membrane peeling for refractory diffuse diabetic macular edema[J]. J Ophthalmic Vis Res, 2010, 5(3): 162-167.
20.	Ivastinovic D, Haas A, Weger M, et al. Vitrectomy for diabetic macular edema and the relevance of external limiting membrane[J]. BMC Ophthalmol, 2021, 21(1): 334. DOI: 10.1186/s12886-021-02095-y.
21.	王俊文, 李拓. 多焦视网膜电图在视网膜疾病中的应用进展[J]. 国际眼科杂志, 2020, 20(10): 1730-1735. DOI: 10.3980/j.issn.1672-5123.2020.10.14.Wang JW, Li T. Progress in the application of multifocal electroretinogram in retinal diseases[J]. Int Eye Sci, 2020, 20(10): 1730-1735. DOI: 10.3980/j.issn.1672-5123.2020.10.14.
22.	Tehrani NM, Riazi-Esfahani H, Jafarzadehpur E, et al. Multifocal electroretinogram in diabetic macular edema; correlation with visual acuity and optical coherence tomography[J]. J Ophthalmic Vis Res, 2015, 10(2): 165-171. DOI: 10.4103/2008-322X.163773.
23.	Iwane Y, Imai H, Yamada H, et al. Removal of subfoveal massive hard exudates through an intentional macular hole in patients with diabetic maculopathy: a report of three cases[J]. Case Rep Ophthalmol, 2022, 13(2): 649-656. DOI: 10.1159/000526150.
24.	朱莉, 苗恒, 胡钦瑞, 等. 不同眼内灌注液对视网膜组织学及功能的影响[J]. 中华实验眼科杂志, 2021, 39(11): 957-967. DOI: 10.3760/cma.j.cn115989-20200810-00575.Zhu L, Miao H, Hu QR, et al. Comparison of the effects of different intraocular infusion solutions on histology and function of rrtina[J]. Chin J Exp Ophthalmol, 2021, 39(11): 957-967. DOI: 10.3760/cma.j.cn115989-20200810-00575.

1. Kim EJ, Lin WV, Rodriguez SM, et al. Treatment of diabetic macular edema[J]. Curr Diab Rep, 2019, 19(9): 68. DOI: 10.1007/s11892-019-1188-4.
2. Takagi H, Otani A, Kiryu J, et al. New surgical approach for removing massive foveal hard exudates in diabetic macular edema[J]. Ophthalmology, 1999, 106(2): 249-257. DOI: 10.1016/S0161-6420(99)90054-4.
3. 杨鑫. 糖尿病相关黄斑病变硬性渗出的危险因素及治疗[J]. 中华实验眼科杂志, 2014, 32(11): 1041-1046. DOI: 10.3760/cma.j.issn.2095-0160.2014.11.016.Yang X. Risk factors and management of diabetes-related macular hard exudates[J]. Chin J Exp Ophthalmol, 2014, 32(11): 1041-1046. DOI: 10.3760/cma.j.issn.2095-0160.2014.11.016.
4. Lin HC, Yang CM, Chen SN, et al. Vitrectomy with internal limiting membrane peeling versus nonsurgical treatment for diabetic macular edema with massive hard exudates[J/OL]. PLoS One, 2020, 15(7): e0236867[2020-07-31]. https://europepmc.org/article/MED/32735583. DOI:10.1371/journal.pone.0236867.
5. Shi R, Guo Z, Yang X, et al. Aggravation of retinal hard exudates after intravitreal anti-vascular endothelial growth factor therapy for cystoid macular edema and the risk factors: a retrospective study[J]. BMC Ophthalmol, 2022, 22(1): 92. DOI: 10.1186/s12886-022-02315-z.
6. Kim HR, Yoon CK, Kim HW, et al. New method of quantitative analysis of hard exudate using optical coherence tomography: application in diabetic macular edema[J]. Korean J Ophthalmol, 2019, 33(5): 399-405. DOI: 10.3341/kjo.2019.0049.
7. 王晓东, 叶瑞珍, 吴晓玉. 多焦视网膜电图对单纯型糖尿病视网膜病变的评估分析[J]. 糖尿病新世界, 2022, 25(11): 5-8, 29. DOI: 10.16658/j.cnki.1672-4062.2022.11.005.Wang XD, Ye RZ, Wu XY. Evaluation and analysis of multifocal electroretinogram for simple diabetic retinopathy[J]. Diabetes New World, 2022, 25(11): 5-8, 29. DOI: 10.16658/j.cnki.1672-4062.2022.11.005.
8. Holm K, Ponjavic V, Lövestam-Adrian M. Using multifocal electroretinography hard exudates affect macular function in eyes with diabetic retinopathy[J]. Graefe’s Arch Clin Exp Ophthalmol, 2010, 248(9): 1241-1247. DOI: 10.1007/s00417-010-1347-4.
9. Chhablani J, Jhingan M, Goud A, et al. Macular edema resolution assessment with implantable dexamethasone in diabetic retinopathy (MERIT): a pilot study[J]. Clin Ophthalmol, 2018, 12: 1205-1211. DOI: 10.2147/OPTH.S163681.
10. Chang YC, Wu WC. Dyslipidemia and diabetic retinopathy[J]. Rev Diabet Stud, 2013, 10(2-3): 121-132. DOI: 10.1900/RDS.2013.10.121.
11. Everett LA, Paulus YM. Laser therapy in the treatment of diabetic retinopathy and diabetic macular edema[J]. Curr Diab Rep, 2021, 21(9): 35. DOI: 10.1007/s11892-021-01403-6.
12. Srinivas S, Verma A, Nittala MG, et al. Effect of intravitreal ranibizumab on intraretinal hard exudates in eyes with diabetic macular edema[J]. Am J Ophthalmol, 2020, 211: 183-190. DOI: 10.1016/j.ajo.2019.11.014.
13. Takaya K, Suzuki Y, Mizutani H, et al. Long-term results of vitrectomy for removal of submacular hard exudates in patients with diabetic maculopathy[J]. Retina, 2004, 24(1): 23-29. DOI: 10.1097/00006982-200402000-00004.
14. Kumagai K, Ogino N, Fukami M, et al. Removal of foveal hard exudates by subretinal balanced salt solution injection using 38-gauge needle in diabetic patients[J]. Graefe’s Arch Clin Exp Ophthalmol, 2020, 258(9): 1893-1899. DOI: 10.1007/s00417-020-04756-y.
15. Domalpally A, Ip MS, Ehrlich JS. Effects of intravitreal ranibizumab on retinal hard exudate in diabetic macular edema: findings from the RIDE and RISE phase Ⅲ clinical trials[J]. Ophthalmology, 2015, 122(4): 779-786. DOI: 10.1016/j.ophtha.2014.10.028.
16. 曾苗, 陈晓, 洪玲, 等. 视网膜下注射平衡盐溶液治疗难治性糖尿病黄斑水肿的初步报告[J]. 中华眼底病杂志, 2020, 36(6): 462-466. DOI: 10.3760/cma.j.cn511434-20190304-00065.Zeng M, Chen X, Hong L, et al. Subretinal injection of balanced salt solution for the resolution of refractory diabetic macular edema[J]. Chin J Ocul Fundus Dis, 2020, 36(6): 462-466. DOI: 10.3760/cma.j.cn511434-20190304-00065.
17. Morizane Y, Kimura S, Hosokawa M, et al. Planned foveal detachment technique for the resolution of diffuse diabetic macular edema[J]. Jpn J Ophthalmol, 2015, 59(5): 279-287. DOI: 10.1007/s10384-015-0390-4.
18. Michalewska Z, Stewart MW, Landers MB 3rd, et al. Vitrectomy in the management of diabetic macular edema in treatment-naïve patients[J]. Can J Ophthalmol, 2018, 53(4): 402-407. DOI: 10.1016/j.jcjo.2017.10.011.
19. Dehghan MH, Salehipour M, Naghib J, et al. Pars plana vitrectomy with internal limiting membrane peeling for refractory diffuse diabetic macular edema[J]. J Ophthalmic Vis Res, 2010, 5(3): 162-167.
20. Ivastinovic D, Haas A, Weger M, et al. Vitrectomy for diabetic macular edema and the relevance of external limiting membrane[J]. BMC Ophthalmol, 2021, 21(1): 334. DOI: 10.1186/s12886-021-02095-y.
21. 王俊文, 李拓. 多焦视网膜电图在视网膜疾病中的应用进展[J]. 国际眼科杂志, 2020, 20(10): 1730-1735. DOI: 10.3980/j.issn.1672-5123.2020.10.14.Wang JW, Li T. Progress in the application of multifocal electroretinogram in retinal diseases[J]. Int Eye Sci, 2020, 20(10): 1730-1735. DOI: 10.3980/j.issn.1672-5123.2020.10.14.
22. Tehrani NM, Riazi-Esfahani H, Jafarzadehpur E, et al. Multifocal electroretinogram in diabetic macular edema; correlation with visual acuity and optical coherence tomography[J]. J Ophthalmic Vis Res, 2015, 10(2): 165-171. DOI: 10.4103/2008-322X.163773.
23. Iwane Y, Imai H, Yamada H, et al. Removal of subfoveal massive hard exudates through an intentional macular hole in patients with diabetic maculopathy: a report of three cases[J]. Case Rep Ophthalmol, 2022, 13(2): 649-656. DOI: 10.1159/000526150.
24. 朱莉, 苗恒, 胡钦瑞, 等. 不同眼内灌注液对视网膜组织学及功能的影响[J]. 中华实验眼科杂志, 2021, 39(11): 957-967. DOI: 10.3760/cma.j.cn115989-20200810-00575.Zhu L, Miao H, Hu QR, et al. Comparison of the effects of different intraocular infusion solutions on histology and function of rrtina[J]. Chin J Exp Ophthalmol, 2021, 39(11): 957-967. DOI: 10.3760/cma.j.cn115989-20200810-00575.

Chinese Journal of Ocular Fundus Diseases

Clinical observation of subretinal injection of compound electrolyte intraocular irrigation solution in the treatment of diabetic macular edema with hard exudate

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