Corticosteroid Injection Combined With Cataract Surgery in Diabetic Eyes.

Sponsor

Damascus University (Other)

Overall Status

Completed

CT.gov ID

NCT05413330

Collaborator

(none)

Enrollment

Location

Arms

18.5

Actual Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

We 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. We will categorize the participants into two groups: the case group who will receive the injection at the end of surgery, and the control group who will have routine cataract surgery with no extra injections.

Condition or Disease	Intervention/Treatment	Phase
Diabete Type 2 Cataract Triamcinolone Acetonide Intravitreal Injection	Drug: Triamcinolone Acetonide	Phase 2/Phase 3

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. We 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, we aim to evaluate the consequences and safety of the injection.

Study Design

Study Type:

Interventional

Actual Enrollment :

73 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective randomized single-blinded clinical trialProspective randomized single-blinded clinical trial

Masking:

Single (Participant)

Masking Description:

Single (Participants)

Primary Purpose:

Prevention

Official Title:

Combined Phacoemulsification Surgery and Intravitreal Triamcinolone Injection Versus Stand-alone Surgery in Patients With Type 2 Diabetes: A Randomized Controlled Trial

Actual Study Start Date :

Sep 12, 2020

Actual Primary Completion Date :

Jan 5, 2022

Actual Study Completion Date :

Mar 29, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IVTA group Patients will receive an intravitreal injection of 4 mg/0.1 mL preservative-free triamcinolone acetonide at the end of surgery.	Drug: Triamcinolone Acetonide 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. Other Names: Kenalog
No Intervention: No injection group Patients will receive no additional treatment to the standard phacoemulsification surgery.

Arm

Intervention/Treatment

Experimental: IVTA group

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

Drug: Triamcinolone Acetonide

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.

Other Names:

Kenalog

No Intervention: No injection group

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

Outcome Measures

Primary Outcome Measures

Change in central subfield mean macular thickness as a measurement of efficacy [T0_ 1 month- T1_ 3 months- T2_ 6 months postoperatively]]
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 [T0: 1 month- T2: 3 months- T3: 6 months postoperatively]
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 [_1 week- T1_ 1 month- T2_ 3 months- T3_ 6 months postoperatively]
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 [T0: 1 week- T1: 1 month- T2: 3 months- T3: 6 months postoperatively]
IOP (in mmHg) will be measured by Goldmann applanation tonometry
No. of subjects with Adverse Events as a measurement of safety [T0: 1 week- T1: 1 month-T2: 3 months- T3: 6 months postoperatively]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts 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.