Completed

Role of Intraoperative Dexamethasone Implant in Improving Outcome of Taut Posterior Hyaloid Removal in Diabetic Macular Edema

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What is being tested

Dexamethasone Drug delivery system (Ozurdex)

+ Dexamethasone Drug delivery system (Ozurdex)

Drug
Who is being recruted

Eye Diseases+4

+ Nervous System Diseases

+ Neurologic Manifestations

From 60 to 65 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: May 2011
See protocol details

Summary

Principal SponsorPost Graduate Institute of Medical Education and Research, Chandigarh
Last updated: October 3, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2011

Actual date on which the first participant was enrolled.

This study is undertaken to determine effect of sustained release dexamethasone implant,Ozurdex in improving outcome of taut posterior hyaloid removal in patients with diabetic macular edema Diabetic macular edema constitute important cause of visual impairment in patients with diabetes.Focal/ grid laser photocoagulation is the standard of care in the management .Several adjuncts including intravitreal corticosteroids, Pegaptanib Sodium , Ranibizumab , Bevacizumab are also been tried.In some patients inspite of multiple lasers or injections macular edema persists as a consequence overlying taut posterior hyaloid membrane which needs to be removed by vitrectomy. The exact role of vitreous in the pathogenesis of diabetic maculopathy remains unclear although it has been implicated as a cause of macular edema via several mechanical and physiologic mechanisms, which include the following (1) destabilization of the vitreous by abnormal glycation and crosslinking of vitreal collagen, leading to traction on the macula, (2) accumulation and concentration of factors causing vasopermeability in the premacular vitreous gel and (3) accumulation of chemoattractant factors in the vitreous, leading to cellular migration to the posterior hyaloid, contraction and macular traction. The observation that release of mechanical traction on the macula with subsequent reduction in DME, either by spontaneous posterior vitreous detachment or with vitrectomy, lends support to this line of reasoning. Furthermore, the evidence that vitrectomy produces improved retinal oxygenation taken together with the evidence that increased oxygenation can reduce DME, suggests an additional physiologic advantage but determination of which eyes might benefit from vitrectomy is the most challenging aspect in the treatment of this condition. Fluorescein angiography, B-scan ultrasonography, and optical coherence tomography may be helpful in this regard. Most often, vitreous surgery is performed when diabetic macular edema persists despite multiple laser treatments. All reports published to date regarding vitrectomy for diabetic macular edema are uncontrolled and nonrandomized patient series. Visual improvement after vitrectomy is related to the duration of edema, as well as the extent of intraretinal lipid and vascular nonperfusion.Even after surgery some patients might need repeat intravitreal bevacizumab or triamcinolone injections to take care of residual macular edema.Intravitreal Triamcinolone Acetonide (TA), a water insoluble steroid, has been shown to reduce the retinal thickness and improve the visual acuity. However, recurrence of macular edema in patients who receive intravitreal TA is a major concern because of its short half life . In search for the ideal corticosteroid preparation, a Dexamethasone Posterior Segment Drug Delivery System (Dexamethasone DDS - Ozurdex®, Allergan Inc, Irvine, California) was recently developed which has generated new interest in this molecule. It is a sustained release intravitreal implant containing 700µg dexamethasone has been approved by the US-FDA (Food and Drug Administration) for treatment of macular edema in retinal vein occlusions. The present study introduces a novel concept of using intraoperative Ozurdex ® implant during taut posterior hyaloid removal and its effect in improving the surgical outcome

Principal SponsorPost Graduate Institute of Medical Education and Research, Chandigarh
Last updated: October 3, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

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

5 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 60 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Eye DiseasesNervous System DiseasesNeurologic ManifestationsSensation DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsVision Disorders

Criteria

2 inclusion criteria required to participate
TPHM causing cystoid macular edema with or without subfoveal serous RD on OCT

Type 1 or 2 Diabetes mellitus

2 exclusion criteria prevent from participating
Known case of ocular hypertension or glaucoma

Macular ischemia on FFA

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Comparison of taut posterior hyaloid removal with (Group B)and without intraoperative ozurdex(Group A)

Group II

Experimental
Comparison of TPHM removal with (Group B) and without (Group A)Ozurdex

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Pooja Bansal

Chandigarh, IndiaOpen Pooja Bansal in Google Maps
CompletedOne Study Center