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Corticosteroid Injection Combined With Cataract Surgery in Diabetic Eyes.

Primary Purpose

Diabete Type 2, Cataract, Triamcinolone Acetonide

Status
Completed
Phase
Phase 2
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Triamcinolone Acetonide
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabete Type 2 focused on measuring diabetes, phacoemulsification, intravitreal, triamcinolone acetonide, diabetic retinopathy, central subfield macular thickness, CSMT, CDVA, IOP

Eligibility Criteria

19 Years - 49 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ● 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.

Exclusion Criteria:

  • • 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.
    • systemic bleeding in the previous 3 months, major systemic surgery in the previous 3 months, or a recent or recurrent cerebrovascular accident, myocardial infarction, or thromboembolic event.

Sites / Locations

  • Damascus University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

IVTA group

No injection group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Change in corrected distance visual acuity CDVA as a measurement of efficacy
CDVA measurements will be taken in metres then converted to Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts (logMAR).
ntraocular pressure (IOP) as a measurement of safety
IOP (in mmHg) will be measured by Goldmann applanation tonometry
No. of subjects with Adverse Events as a measurement of safety
An adverse event (AE) is defined as any undesirable experience occurring to a subject during the study, whether or not considered related to the investigational product. All adverse events reported spontaneously by the subject or observed by the principal investigator or his staff will be recorded. Endophthalmitis in particular will be recorded.

Full Information

First Posted
June 7, 2022
Last Updated
April 24, 2023
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT05413330
Brief Title
Corticosteroid Injection Combined With Cataract Surgery in Diabetic Eyes.
Official Title
Combined Phacoemulsification Surgery and Intravitreal Triamcinolone Injection Versus Stand-alone Surgery in Patients With Type 2 Diabetes: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 12, 2020 (Actual)
Primary Completion Date
January 5, 2022 (Actual)
Study Completion Date
March 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Cataract and diabetic retinopathy (DR) represent two of the top five leading causes of global impaired vision and blindness according to the WHO. Higher incidence and faster cataract progression are well-established in diabetic patients, especially those with higher glycated hemoglobin values. Further, it is estimated that up to 20% of all cataract surgery is performed on diabetic patients. The investigators aim in this study to contribute to investigating the efficacy of triamcinolone acetonide injection at the end of phacoemulsification surgery in patients with type 2 diabetes in comparison with the standard phacoemulsification surgery: whether it blunts the initiation as well as the progression of diabetic macular edema and diabetic retinopathy, and improves visual outcomes. Besides, The investigators aim to evaluate the consequences and safety of the injection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabete Type 2, Cataract, Triamcinolone Acetonide, Intravitreal Injection
Keywords
diabetes, phacoemulsification, intravitreal, triamcinolone acetonide, diabetic retinopathy, central subfield macular thickness, CSMT, CDVA, IOP

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized single-blinded clinical trial
Masking
Participant
Masking Description
Single (Participants)
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IVTA group
Arm Type
Experimental
Arm Description
Patients will receive an intravitreal injection of 4 mg/0.1 mL preservative-free triamcinolone acetonide at the end of surgery.
Arm Title
No injection group
Arm Type
No Intervention
Arm Description
Patients will receive no additional treatment to the standard phacoemulsification surgery.
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide
Other Intervention Name(s)
Kenalog
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in central subfield mean macular thickness as a measurement of efficacy
Description
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.
Time Frame
T0_ 1 month- T1_ 3 months- T2_ 6 months postoperatively]
Title
Change in diabetic retinopathy grade as a measurement of efficacy
Description
The primary endpoint is the change in diabetic retinopathy grade as compared to baseline within the first 6 months postoperatively.
Time Frame
T0: 1 month- T2: 3 months- T3: 6 months postoperatively
Secondary Outcome Measure Information:
Title
Change in corrected distance visual acuity CDVA as a measurement of efficacy
Description
CDVA measurements will be taken in metres then converted to Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts (logMAR).
Time Frame
_1 week- T1_ 1 month- T2_ 3 months- T3_ 6 months postoperatively
Title
ntraocular pressure (IOP) as a measurement of safety
Description
IOP (in mmHg) will be measured by Goldmann applanation tonometry
Time Frame
T0: 1 week- T1: 1 month- T2: 3 months- T3: 6 months postoperatively
Title
No. of subjects with Adverse Events as a measurement of safety
Description
An adverse event (AE) is defined as any undesirable experience occurring to a subject during the study, whether or not considered related to the investigational product. All adverse events reported spontaneously by the subject or observed by the principal investigator or his staff will be recorded. Endophthalmitis in particular will be recorded.
Time Frame
T0: 1 week- T1: 1 month-T2: 3 months- T3: 6 months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ● 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. Exclusion Criteria: • 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. systemic bleeding in the previous 3 months, major systemic surgery in the previous 3 months, or a recent or recurrent cerebrovascular accident, myocardial infarction, or thromboembolic event.
Facility Information:
Facility Name
Damascus University
City
Damascus
ZIP/Postal Code
00000
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18471640
Citation
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.
Results Reference
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11955902
Citation
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.
Results Reference
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PubMed Identifier
23499065
Citation
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.
Results Reference
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PubMed Identifier
34417781
Citation
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Results Reference
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PubMed Identifier
10900103
Citation
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.
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Corticosteroid Injection Combined With Cataract Surgery in Diabetic Eyes.

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