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ORIGINAL ARTICLE
Year : 2022  |  Volume : 35  |  Issue : 3  |  Page : 1499-1504

Comparative study between difluprednate and prednisolone acetate after phacoemulsification in diabetic patients


Department of Ophthalmology, Faculty of Medicine, Menoufia University, Menoufia, Egypt

Date of Submission30-Mar-2022
Date of Decision21-Apr-2022
Date of Acceptance24-Apr-2022
Date of Web Publication29-Oct-2022

Correspondence Address:
Ahmed M M Elsehemy
Menoufia
Egypt
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/mmj.mmj_110_22

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  Abstract 


Objective
To compare difluprednate 0.5 mg (0.05%) versus prednisolone acetate 10 mg MedCalc Software (1%) after cataract procedures in diabetic patients regarding their safety and efficacy in postoperative inflammation.
Background
Cataract is the world's most prevalent cause of vision loss, affecting mostly the elderly. Cataract surgery is now the sole therapy option. As a result, around eight million cataract operations are conducted each year. Furthermore, the higher life expectancy supports the likelihood of even more procedures in the coming years.
Patients and methods
This prospective interventional comparative research included 74 eyes of diabetic patients with cataract, attending Menoufia University Hospital outpatient clinic, undergoing uncomplicated phacoemulsification. They were divided into two equal groups, each one included 37 patients. The trial duration was from 6 to 12 months.
Results
Both difluprednate and prednisolone groups showed similar improvements in corneal edema (29.7 vs. 29.7%, respectively), with no substantial variations in the two treatment groups (P = 0.493).
Conclusions
According to the findings of this research, difluprednate seems to be equally safe and efficacious as prednisolone acetate in managing postoperative inflammation and pain in patients having phacoemulsification.

Keywords: cataract, diabetic patients, difluprednate, phacoemulsification, prednisolone


How to cite this article:
Zaky MA, Mandour SS, Elsehemy AM, Basiony AI. Comparative study between difluprednate and prednisolone acetate after phacoemulsification in diabetic patients. Menoufia Med J 2022;35:1499-504

How to cite this URL:
Zaky MA, Mandour SS, Elsehemy AM, Basiony AI. Comparative study between difluprednate and prednisolone acetate after phacoemulsification in diabetic patients. Menoufia Med J [serial online] 2022 [cited 2024 Mar 29];35:1499-504. Available from: http://www.mmj.eg.net/text.asp?2022/35/3/1499/359649




  Introduction Top


Cataract is the world's most prevalent cause of vision loss, affecting mostly the elderly. Cataract surgery is now the sole therapy option. As a result, around eight million cataract operations are conducted each year. Furthermore, the higher life expectancy supports the likelihood of even more procedures in the coming years[1].

Fortunately, cataract surgery, particularly phacoemulsification or short-incision cataract surgery, is one of the most successful procedures. Patient expectations for visual results and comfort procedures have risen as a result of technological advancements in this sector[2].

Diabetes mellitus is a long-term systemic condition that may impair any ocular structure, with cataract being the most prevalent consequence. Cataract surgery is now a frequent and safe treatment because of technological advances. Diabetic macular edema (ME), postoperative ME, and diabetic retinopathy development are all vision-threatening conditions[3].

Difluprednate is a derivative of prednisolone acetate enhanced by two fluorinations at carbons 6 and 9, a butyrate group at carbon 17 that adds anti-inflammatory action, and an acetic acid addition at carbon 21 that increases penetration[4].

Pseudophakic cystoid macular edema is a frequent consequence after cataract operation, both simple and difficult, and is connected to postoperative inflammation and the production of inflammatory mediators. Topical steroid medications were used to minimize the negative consequences of inflammation and have been used to prevent and treat pseudophakic cystoid macular edema[5].

The goal of this research was to examine the safety and effectiveness of difluprednate and prednisolone acetate following cataract surgery in diabetic individuals in terms of postoperative inflammation.


  Patients and methods Top


This prospective interventional comparative study included 74 diabetic eyes with cataract that attended Menoufia University Hospital outpatient clinic, divided into two equal groups, each one included 37 patients. In this study, difluprednate 0.05% (diflustero eye drops; Orchidia Al Obour, Dakahlia Governorate, Egypt Company product) was compared with prednisolone acetate 1% (predforte eye drops; Allergan Company product Nasr City, Cairo, Egypt) as a postoperative anti-inflammatory agent. Inclusion criteria: 18-year-old or older diabetic male or female, patients with significant cataract who will undergo uneventful cataract surgery, any level of nonproliferative diabetic retinopathy, and preoperative optical coherence tomography (OCT) showing no ME. Exclusion criteria: total lens opacity, hard brown cataract, previous intraocular surgery, complicated cataract surgery, such as the usages of iris hooks or iris stretchers, any level of proliferative diabetic retinopathy, a history of ocular pathology such as uveitis, iritis, or intraocular inflammation, macular pathology of the retina, any verified or believed active viral or bacterial keratoconjunctivitis, and history of steroid-related intraocular pressure (IOP) rises in the eye studied. Study procedure and surgical method: all study patients were carefully examined preoperatively, first day, 1 week, 2 weeks, and 1-month postoperative. Ophthalmic examination will include the following: uncorrected visual acuity and best-corrected visual acuity (BCVA), IOP measuring by applanation tonometry, corneal examination, and anterior-chamber examination and grading of flare and cells, lens and fundus examination, and macular thickness evaluation by OCT. Spectral Domain Heidelberg OCT INNOVA Medical, Pasadena, CA 91101, United States (Spectralis OCT) was used before and after the procedure to take fast macular thickness images. Cataract-surgery procedure was carried out by the same surgeon to minimize the bias. Aiming at a standard procedure, all surgeries will be conducted under local anesthetic agent, using the same phacomachine and the same parameters. Two groups of patients will be formed, group 1 will be treated with topical difluprednate and group 2 with prednisolone acetate as a postoperative anti-inflammatory in addition to topical antibiotic.

Consent statement

Ethical considerations and confidentiality: all research methods will be performed out and authorized by the Menoufia Faculty of Medicine's Ethical Committee, in compliance with the Helsinki Declaration.

Statistical analysis

The data will be tabulated and statistically evaluated utilizing SPSS IMP Corp., Armonk, New York, USA (Statistical Package for Social Sciences) program version 26.0, Microsoft Excel 2016, and the MedCalC IMP Corp., Armonk, New York, USA program, version 19.1. Descriptive statistics were calculated for numerical parametric data such as mean ± SD and minimum and maximum ranges, as well as numerical nonparametric data such as average and first and third interquartile ranges, and categorical data such as number and percent.


  Results Top


This prospective interventional comparative study was conducted at 74 cataractous eyes of 55 diabetic patients, attending Menoufia University Hospital outpatient clinic, undergoing uncomplicated phacoemulsification. They were divided into two equal groups, each one included 37 patients.

Demographic parameters among the two groups were tested. The mean ages in difluprednate group 2 were 56.14 ± 7.25 and 54.59 ± 7.78 years, respectively. There was statistically no substantial variation between the two groups regarding age (P = 0.420). About 40.5% cases were males and 59.5% were females in Group 1, while 35.1% cases were males and 64.9% were females in group 2 with no substantial variation among the two groups regarding sex (P = 0.632) [Table 1].
Table 1: Demographic characteristics among the studied groups

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There was comparison between the studied groups regarding BCVA. No substantial variation was observed comparing the two treatment groups at any time point (P > 0.05). There were substantial changes in BCVA throughout the follow-up period in both group 1 and group 2 [Table 2].
Table 2: Comparison between the studied groups regarding best-corrected visual acuity

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There was comparison between the studied groups regarding IOP. No substantial variation was observed comparing the two treatment groups at any time point as regards IOP (P > 0.05). There were substantial changes in IOP throughout the follow-up period in both group 1 and group 2 [Table 3].
Table 3: Comparison between the studied groups regarding intraocular pressure

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Preoperatively, the mean OCT macula measurement in group 1 was 262.81 ± 44.7, while in group 2, it was 262.35 ± 44.7. At the research ending, the mean OCT macula measurement in group 1 was increased to 270.54 ± 46.5, while in group 2, it was 268.0 ± 45.9. No substantial variation was observed in the groups at any time point (P > 0.05) [Table 4].
Table 4: Comparison between the studied groups regarding optical coherence tomography macula at different periods

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The incidence of conjunctival hyperemia did not differ substantially in the two treated groups (P = 0.722). Both difluprednate and prednisolone groups showed similar improvements in corneal edema (29.7 vs. 29.7%, respectively), with no substantial distinction between the two treated groups (P = 0.493). Throughout the trial, all groups demonstrated a substantial decrease in ocular symptomatology such as discomfort and photophobia, with no significant differences between groups (P = 1.00 and 0.493, respectively). Tolerance criteria included burning, alien-body feeling, itching, and others. In group 1, the prevalence of burning, foreign body feeling, and itching was 37.8, 29.7, and 16.2%, respectively, whereas in the prednisolone group, the prevalence was 51.4, 37.8, and 24.3%, with no substantial distinctions between groups [Table 5].
Table 5: Comparison between the studied groups regarding postoperative ocular symptomatology

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  Discussion Top


A total of 74 eyes in diabetic patients with cataracts were included in this prospective interventional comparative research, attending Menoufia University Hospital outpatient clinic, undergoing uncomplicated phacoemulsification. They were divided into two equal groups, each one included 37 patients. The trial lasted anywhere from 6 to 12 months.

As regards demographic characteristics among the two studied groups, the mean ages in difluprednate and group 2 were 56.14 ± 7.25 and 54.59 ± 7.78 years, respectively. In terms of age, there was no substantial distinction in the two groups (P = 0.420). About 40.5% cases were males and 59.5% were females in group 1, while 35.1% cases were males and 64.9% were females in group 2, with no substantial distinction in the two groups regarding sex (P = 0.632).

In accordance with our results, the study of Palacio-Pastrana et al.[6] reported that there were no variations in demographics among the treatment groups. A total of 178 patients were randomized in a 1: 1 ratio to receive difluprednate emulsion 0.05% (PRO-145; Laboratorios Sophia, SA de CV, Zapopan, Jalisco, Mexico; n = 88) or prednisolone acetate 1% (Prednefrin SF; Allergan Inc., Irvine, California, USA; n = 90). The average age (SD) was 65.3 12.0 years (range, 18–89), and 54.4% of the patients were female.

Also, in the study of Anand and Garg,[7] patients in group 1 (0.05% topical difluprednate ophthalmic emulsion) were 58.97 ± 10.56 years old, whereas those in group 2 (1% prednisolone acetate ophthalmic solution) were 60.47 ± 10.53 years old. The total average age of the participants in the two research groups did not vary substantially (P > 0.05).

The present study showed that regarding clinical characteristics, regarding BCVA, at any time point, no substantial differences between the two treated groups were identified (P > 0.05). There were no substantial variations in IOP in the two treated groups at any time point (P > 0.05).

Our findings were backed up by Palacio-Pastrana et al.[6] investigation, which found no substantial variations between the groups treated.

In the study of Garg et al.[4] at the conclusion of the trial, all patients in both groups improved their visual acuity, with a P value less than 0.001. Both groups of patients had ultimate BCVA of 6/9–6/6, with no significant variation between them.

Also, according to Shankar and Vivek[8] at the conclusion of the trial, all patients in both groups improved their visual acuity, with a P value less than 0.001. With no statistically relevant variance between the two trial groups, all of the patients in both groups had final BCVA of 6/9–6/6. After surgery, group 1 received a topical 1% prednisolone acetate ophthalmic suspension six times a day. After surgery, group 2 received 0.05% difluprednate ophthalmic emulsion six times a day.

The current study showed that the two treatment groups had no significant differences at any time point as regards AC cell (P > 0.05).

In accordance with our results, the study of Panda et al.[9] reported that the AC response at 1 week postoperatively in group 1 (group 1; difluprednate 0.05%, n = 90) revealed an equal proportion of patients with grade 0 (n = 44, 48.9%) and grade 1 (n = 44, 48.9%) aqueous cells 1 week after surgery. Grade-2 aqueous cells were seen in 2.2% of individuals (n = 2). The majority of patients (n = 48, 52.7%) in group 2 (prednisolone acetate 1%) had grade-0 aqueous cells, while 46.2% (n = 42) had grade-1 and 1.1% (n = 1) had grade-2 aqueous cells.

Also, Garg et al.[4] demonstrated that on day 1, 58% of patients in group 1 had grade-1 aqueous cells and 42% had grade 2, while 54% of patients in group 2 had grade-2 cells and 40% had grade-1 aqueous cells. At the conclusion of the trial, 98% of patients in group 1 had grade-0 cells, whereas all patients in group 2 had grade-0 cells, with no substantial variations in groups detected at any time point. Following surgery, patients in group 1 got 1% prednisolone acetate ocular suspension, while patients in group 2 received 0.05% difluprednate ophthalmic emulsion.

In the study in our hands, regarding AC flare, the two treatment groups had no significant differences at any time point as regards AC flare (P > 0.05).

On day 1, 68% of patients in group 1 had grade-1 aqueous flare and 14% had grade 2, whereas 82% of patients in group 2 had grade-1 flare and 12% had grade-2 aqueous flare, according to Garg et al.[4] at the conclusion of the trial, all of the patients in both groups had a grade of 0, with no considerable variations in groups identified at any time point.

Similar findings were noted by Palacio-Pastrana et al.[6] at day 1 (χ2 (1)=0.141, P = 0.759), the proportion of patients with a grade-0 (none) AC flare was statistically equal among PRO-145 (44.7%, n = 38) and prednisolone (41.9%, n = 36).

While, in the study of KhalafAllah et al.[10], difluprednate was better in clearing AC cells at 1 week (odds ratio = 2.5, P > 0.00001) and 2 weeks (odds ratio = 2.5, P = 0.04) following short-incision cataract surgery, as well as clearing the AC flare at 2 weeks (odds ratio = 6.7, P = 0.04), according to their systematic analysis. Difluprednate was also shown to be better regarding corneal clearing one day (odds ratio = 2.6, P = 0.02) and 1 week (odds ratio = 1.96, P = 0.0007) following phacoemulsification surgery. At 1 month, however, both medicines were equally effective.

Our results showed that the mean OCT macula measurement in group 1 was 262.81 ± 44.7, while in group 2, it was 262.35 ± 44.7. At the conclusion of the research, the median OCT macula measurement in group 1 was increased to 270.54 ± 46.5, while in group 2, it was 268.0 ± 45.9. There were no substantial variances across the two treated groups at any time point (P > 0.05).

In accordance with our results, the study of Palacio-Pastrana et al.[6] reported that there were no substantial differences between their groups tested according to mean OCT macula measurement.

While, in the study of Shankar and Vivek[8], ocular discomfort was not experienced by any of the individuals in group 1. About 96% of participants in group 2 experienced no ocular discomfort. The remaining 4% had minor pain but did not need medicine. At the conclusion of the research, 98% of patients in group 1 and 100% of patients in group 2 had aqueous cell clearance.

In the study of Garg et al.[4] on day 1, 46% of patients in group 1 had grade-1 ocular discomfort and 50% had grade 2, while 44% of patients in group 2 had grade-1 pain and 54% had grade 2. At the conclusion of the trial, none of the patients in group 1 complained of any ocular pain, while only 4% of the patients in group 2 had minor discomfort. There were no substantial variations among the groups.

Shankar and Vivek[8] reported that the visual analog scale was utilized to measure ocular discomfort in both groups, and the results were compared. None of the patients in group 1 and 96% of the patients in group 2 developed eye discomfort at the conclusion of the research (grade 1). In both groups, the difference was statistically insignificant (P > 0.05).

In their investigation, Korenfeld et al.[11] found that difluprednate ophthalmic emulsion 0.05% reduced pain and inflammation when compared with a control group. In a trial conducted by Foster et al.[12], pain relief with difluprednate was marginally quicker than with prednisolone acetate ophthalmic suspension.


  Conclusion Top


Difluprednate seems to be equally safe and efficacious as prednisolone acetate in managing postoperative inflammation and pain in patients receiving phacoemulsification, according to the findings of this research.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Khairallah M, Kahloun R, Bourne R, Limburg H, Flaxman SR, Jonas JB, et al. Number of people blind or visually impaired by cataract worldwide and in world regions, 1990 to 2010. Invest Ophthalmol Vis Sci 2015; 56:6762–6769.  Back to cited text no. 1
    
2.
Pager CK. Expectations and outcomes in cataract surgery. Arch Ophthalmol 2004; 122:1788.  Back to cited text no. 2
    
3.
Kiziltoprak H, Tekin K, Inanc M, Goker YS. Cataract in diabetes mellitus. World J Diabetes 2019; 10:140–153.  Back to cited text no. 3
    
4.
Garg P, Tuteja N, Qayum S. To study the efficacy of difluprednate ophthalmic emulsion and prednisolone acetate ophthalmic suspension on post-operative inflammation in cataract surgery. J Clin Diagn Res 2016; 10:NC05–NC08.  Back to cited text no. 4
    
5.
Grzybowski A, Kanclerz P, Huerva V, Ascaso FJ, Tuuminen R. Diabetes and phacoemulsification cataract surgery: difficulties, risks and potential complications. J Clin Med 2019; 8:716.  Back to cited text no. 5
    
6.
Palacio-Pastrana C, Chávez-Mondragón E, Soto-Gómez A, Suárez-Velasco R, Montes-Salcedo M, de Ortega LF, et al. Difluprednate 0.05% versus prednisolone acetate post-phacoemulsification for inflammation and pain: an efficacy and safety clinical trial. Clin Ophthalmol 2020; 14:1581.  Back to cited text no. 6
    
7.
Anand N, Garg R. Comparison of efficacy of difluprednate emulsion vs topical prednisolone acetate on post phacoemulsification inflammation. Int J Contemp Med Res 2019; 6:2393–7379.  Back to cited text no. 7
    
8.
Shankar L, Vivek J. To study the efficacy of difluprednate ophthalmic emulsion and prednisolone acetate ophthalmic suspension on post-operative inflammation in cataract surgery. Int J Sci Res 2019; 7:583.  Back to cited text no. 8
    
9.
Panda B, Nanda A, Swain SC. Therapeutic efficacy of difluprednate 0.05% versus prednisolone acetate 1% in controlling inflammation and macular oedema following phacoemulsification: an optical coherence tomography-based study. Cureus 2021; 13:e14673.  Back to cited text no. 9
    
10.
KhalafAllah MT, Basiony A, Salama A. Difluprednate versus prednisolone acetate after cataract surgery: a systematic review and meta-analysis. BMJ Open 2019; 9:e026752.  Back to cited text no. 10
    
11.
Korenfeld MS, Silverstein SM, Cooke DL. Difluprednate ophthalmic emulsion 0.05% (Durezol) Study Group. Difluprednate ophthalmic emulsion 0.05% for postoperative inflammation and pain. J Cataract Refract Surg 2009; 35:26–34.  Back to cited text no. 11
    
12.
Foster CS, Davanzo R, Flynn TE, McLeod K, Vogel R, Crockett RS. Durezol (difluprednate ophthalmic emulsion 0.05%) compared with Pred Forte 1% ophthalmic suspension in the treatment of endogenous anterior uveitis. J Ocul Pharmacol Ther 2010; 26:475–483.  Back to cited text no. 12
    



 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5]



 

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