Corticosteroid Injection Combined With Cataract Surgery in Diabetic Eyes.

April 24, 2023 updated by: Damascus University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in central subfield mean macular thickness as a measurement of efficacy
Time Frame: 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.
T0_ 1 month- T1_ 3 months- T2_ 6 months postoperatively]
Change in diabetic retinopathy grade as a measurement of efficacy
Time Frame: 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.
T0: 1 month- T2: 3 months- T3: 6 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in corrected distance visual acuity CDVA as a measurement of efficacy
Time Frame: _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).
_1 week- T1_ 1 month- T2_ 3 months- T3_ 6 months postoperatively
ntraocular pressure (IOP) as a measurement of safety
Time Frame: T0: 1 week- T1: 1 month- T2: 3 months- T3: 6 months postoperatively
IOP (in mmHg) will be measured by Goldmann applanation tonometry
T0: 1 week- T1: 1 month- T2: 3 months- T3: 6 months postoperatively
No. of subjects with Adverse Events as a measurement of safety
Time Frame: 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.
T0: 1 week- T1: 1 month-T2: 3 months- T3: 6 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damascus University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2020

Primary Completion (Actual)

January 5, 2022

Study Completion (Actual)

March 29, 2022

Study Registration Dates

First Submitted

June 7, 2022

First Submitted That Met QC Criteria

June 7, 2022

First Posted (Actual)

June 10, 2022

Study Record Updates

Last Update Posted (Actual)

April 26, 2023

Last Update Submitted That Met QC Criteria

April 24, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDMS-Opthal-01-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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