Corticosteroid Injection Combined With Cataract Surgery in Diabetic Eyes.

NCT05413330 | Completed Phase 2 DMC

• 1 other identifier: UDMS-Opthal-01-2022
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim in this study to investigate the effect of intravitreal triamcinolone acetonide injection on the development of macular edema and the progression of diabetic retinopathy. Whether this injection hastens cataract surgery results or not. The investigators will categorize the participants into two groups: the case group who will receive the injection at the end of the surgery, and the control group who will have routine cataract surgery with no extra injections.

Conditions

Diabete Type 2; Cataract; Triamcinolone Acetonide; Intravitreal Injection

Keywords

diabetes; phacoemulsification; intravitreal; triamcinolone acetonide; diabetic retinopathy; central subfield macular thickness; CSMT; CDVA; IOP

Outcome Measures

Primary Outcomes (2)

• Change in central subfield mean macular thickness as a measurement of efficacy

  The primary endpoint is the change in central subfield mean macular thickness in the 1 mm area (central subfield macular thickness, CSMT) as compared to baseline within the first 6 months postoperatively.

  T0_ 1 month- T1_ 3 months- T2_ 6 months postoperatively]

• Change in diabetic retinopathy grade as a measurement of efficacy

  The primary endpoint is the change in diabetic retinopathy grade as compared to baseline within the first 6 months postoperatively.

  T0: 1 month- T2: 3 months- T3: 6 months postoperatively

Secondary Outcomes (3)

• Change in corrected distance visual acuity CDVA as a measurement of efficacy

  _1 week- T1_ 1 month- T2_ 3 months- T3_ 6 months postoperatively

• ntraocular pressure (IOP) as a measurement of safety

  T0: 1 week- T1: 1 month- T2: 3 months- T3: 6 months postoperatively

• No. of subjects with Adverse Events as a measurement of safety

  T0: 1 week- T1: 1 month-T2: 3 months- T3: 6 months postoperatively

Study Arms (2)

IVTA group

EXPERIMENTAL

Patients will receive an intravitreal injection of 4 mg/0.1 mL preservative-free triamcinolone acetonide at the end of surgery.

Drug: Triamcinolone Acetonide

No injection group

NO INTERVENTION

Patients will receive no additional treatment to the standard phacoemulsification surgery.

Interventions

Triamcinolone Acetonide DRUG

Intravitreal injection of 4 mg/0.1 mL preservative-free triamcinolone acetonide at the end of phacoemulsification surgery will be injected at 3.5 mm inferolateral and posterior to the limbus.

Also known as: Kenalog

IVTA group

Eligibility Criteria

• Age: 19 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ● A history of diabetes mellitus DM type II that is well-confirmed by an endocrinologist.
• Senile cataract that is causing visual disturbance as demonstrated by clinical examination.
• CDVA of no more than 20/ 40, finger count and hand movement vision are included. Too.
• Diabetic retinopathy that falls in one of the following categories according to the International Clinical Diabetic Retinopathy Disease Severity Scale: No DR- mild NPDR- moderate NPDR.
• A healthy-looking central macula, or Clinically Significant Macular Edema (CSME), or edema that is apparent on Fundus Fluorescent Angiography (FFA) or OCT, as well as a treatment-resistant diabetic macular edema in the past 24 months or microaneurysms at foveal avascular zone (FAZ) borders not amenable to laser therapy.
• Both sexes, Age 18 years or older.
• One eye per patient will be included.
• The surgery will be performed by the same surgeon and the samIOL design will be used.

You may not qualify if:

• A history of diabetes mellitus DM type I that is well-confirmed by an endocrinologist or no history of DM.
• CDVA that is better than 20/40.
• functionally monocular patient as a result of moderate to severe visual impairment in the contralateral eye, as per the definition of the International Statistical Classification of Diseases and Related Health Problems, 10th revision (6).
• The presence of pathologies other than diabetic retinopathy and cataract that may justify visual acuity decline (e.g. corneal disease, age related macular degeneration, macular hole, etc…).
• patients will be excluded if they had an increased risk for developing CME in the study eye because of a complication during the current or previous intraocular surgery, intraocular inflammation or uveitis, retinal vein occlusion, or macular pathology that might influence visual function, other than diabetic macular edema.
• Patients with pseudoexfoliation syndrome, Fuchs endothelial dystrophy, or post-traumatic cataract in the study eye.
• Diabetic retinopathy that falls in one of the following categories according to the International Clinical Diabetic Retinopathy Disease Severity Scale: severe NPDR, proliferative DR, or vitreous hemorrhage requiring pan-retinal photocoagulation or vitrectomy.
• Patients who used topical NSAIDs, topical or systemic corticosteroids before surgery.
• patients who received an intravitreal injection with any kind of anti-VEGF in the study eye in the previous 6 weeks, or an intraocular or periocular corticosteroid injection in the previous 3 months.
• patients who received PRP during the past 3 months.
• Contraindications for any of the investigated drugs, particularly patients with glaucoma, IOP of 21mm Hg or higher, previous steroid-induced IOP elevation, or ganglion cell/ RNFL complex injury on OCT image.
• History of steroid hypersensitivity.
• Patients who are taking steroids PO with a total dosage of more than 5 mg/ day.
• Pregnant and breastfeeding ladies.
• Previous surgery on the study eye.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Damascus University

Damascus, 00000, Syria

Location

Related Publications (11)

• Kim SY, Yang J, Lee YC, Park YH. Effect of a single intraoperative sub-Tenon injection of triamcinolone acetonide on the progression of diabetic retinopathy and visual outcomes after cataract surgery. J Cataract Refract Surg. 2008 May;34(5):823-6. doi: 10.1016/j.jcrs.2008.01.018.

  PMID: 18471640 BACKGROUND

• Chung J, Kim MY, Kim HS, Yoo JS, Lee YC. Effect of cataract surgery on the progression of diabetic retinopathy. J Cataract Refract Surg. 2002 Apr;28(4):626-30. doi: 10.1016/s0886-3350(01)01142-7.

  PMID: 11955902 BACKGROUND

• Lundstrom M, Barry P, Henry Y, Rosen P, Stenevi U. Visual outcome of cataract surgery; study from the European Registry of Quality Outcomes for Cataract and Refractive Surgery. J Cataract Refract Surg. 2013 May;39(5):673-9. doi: 10.1016/j.jcrs.2012.11.026. Epub 2013 Mar 14.

  PMID: 23499065 BACKGROUND

• Simons RWP, Wielders LHP, Nuijts RMMA, Veldhuizen CA, van den Biggelaar FJHM, Winkens B, Schouten JSAG, Dirksen CD; ESCRS PREMED Study Group. Economic evaluation of prevention of cystoid macular edema after cataract surgery in diabetic patients: ESCRS PREMED study report 6. J Cataract Refract Surg. 2022 May 1;48(5):555-563. doi: 10.1097/j.jcrs.0000000000000785.

  PMID: 34417781 BACKGROUND

• Mittra RA, Borrillo JL, Dev S, Mieler WF, Koenig SB. Retinopathy progression and visual outcomes after phacoemulsification in patients with diabetes mellitus. Arch Ophthalmol. 2000 Jul;118(7):912-7.

  PMID: 10900103 BACKGROUND

• Mentes J, Erakgun T, Afrashi F, Kerci G. Incidence of cystoid macular edema after uncomplicated phacoemulsification. Ophthalmologica. 2003 Nov-Dec;217(6):408-12. doi: 10.1159/000073070.

  PMID: 14573973 BACKGROUND

• Lee R, Wong TY, Sabanayagam C. Epidemiology of diabetic retinopathy, diabetic macular edema and related vision loss. Eye Vis (Lond). 2015 Sep 30;2:17. doi: 10.1186/s40662-015-0026-2. eCollection 2015.

  PMID: 26605370 BACKGROUND

• Diabetic Retinopathy Clinical Research Network; Elman MJ, Aiello LP, Beck RW, Bressler NM, Bressler SB, Edwards AR, Ferris FL 3rd, Friedman SM, Glassman AR, Miller KM, Scott IU, Stockdale CR, Sun JK. Randomized trial evaluating ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Ophthalmology. 2010 Jun;117(6):1064-1077.e35. doi: 10.1016/j.ophtha.2010.02.031. Epub 2010 Apr 28.

  PMID: 20427088 BACKGROUND

• Eriksson U, Alm A, Bjarnhall G, Granstam E, Matsson AW. Macular edema and visual outcome following cataract surgery in patients with diabetic retinopathy and controls. Graefes Arch Clin Exp Ophthalmol. 2011 Mar;249(3):349-59. doi: 10.1007/s00417-010-1484-9. Epub 2010 Sep 9.

  PMID: 20827486 BACKGROUND

• Wielders LHP, Schouten JSAG, Winkens B, van den Biggelaar FJHM, Veldhuizen CA, Findl O, Murta JCN, Goslings WRO, Tassignon MJ, Joosse MV, Henry YP, Rulo AHF, Guell JL, Amon M, Kohnen T, Nuijts RMMA; ESCRS PREMED Study Group. European multicenter trial of the prevention of cystoid macular edema after cataract surgery in nondiabetics: ESCRS PREMED study report 1. J Cataract Refract Surg. 2018 Apr;44(4):429-439. doi: 10.1016/j.jcrs.2018.01.029.

  PMID: 29778106 BACKGROUND

• Zaher Addeen S, Shaddoud I. Combined phacoemulsification surgery and intravitreal triamcinolone injection versus stand-alone surgery in patients with type 2 diabetes: a prospective randomized trial. BMC Ophthalmol. 2022 Nov 19;22(1):445. doi: 10.1186/s12886-022-02676-5.

  PMID: 36401233 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cataract; Diabetes Mellitus; Diabetic Retinopathy

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lens Diseases; Eye Diseases; Retinal Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single (Participants)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective randomized single-blinded clinical trial

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 10, 2022
• Study Start: September 12, 2020
• Primary Completion: January 5, 2022
• Study Completion: March 29, 2022
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)