Intraoperative Dexamethasone Implant Improves Outcome of Cataract Surgery With Diabetic Macular Edema
Condition: Macular Edema, Cystoid; Vision Disorders; Diabetic Macular Edema; Cystoid Macular Edema Following Cataract Surgery; Cataract
MeSH terms: Vision Disorders; Cataract; Macular Edema; Edema
Intervention: Dexamethasone Drug delivery system (Ozurdex); Cataract surgery
Intervention description: It is a sustained release intravitreal implant containing 700µg dexamethasone has been approved by the US-FDA (Food and Drug Administration).; Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 35 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is undertaken to determine the effect of intravitreal long acting dexamethasone
      implant, (Ozurdex®) in improving outcome of cataract surgery in patients with diabetic
      macular edema.

      Diabetic Macular Edema and cataract constitute important causes of visual impairment in
      patients with diabetes. Cataract surgery in patients with diabetic retinopathy is associated
      with progression of retinopathy.

      Several modalities such as non-steroidal anti-inflammatory agents, carbonic anhydrase
      inhibitors, corticosteroids, hyperbaric oxygen, laser photocoagulation and vitrectomy with
      internal limiting membrane peeling have been tried for managing inflammatory cystoid 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 as the patients need
      multiple repeat injections.

      In search for the ideal corticosteroid preparation, a Dexamethasone Posterior Segment Drug
      Delivery System (Dexamethasone DDS - Ozurdex®, Allergan Inc, Irvine, California) was recently
      developed. Promising results have been shown in certain patients with persistent diabetic
      macular edema receiving this intravitreal drug delivery system with improvement in visual
      acuity

      The present study introduces a novel concept of using intraoperative Ozurdex ® implant in
      patients with diabetes mellitus while undergoing cataract surgery to minimize the worsening
      of diabetic maculopathy.
    

Eligibility criteria:

        Inclusion Criteria:

        The patients of Type 2 Diabetes Mellitus fulfilling the following inclusion criteria shall
        be enrolled in the study:

          1. Presence of visually significant cataract requiring surgery (any grade)

          2. Patients with Non-proliferative Diabetic Retinopathy (NPDR) with/without clinically
             significant macular edema (CSME)

          3. Patients with Proliferative Diabetic Retinopathy (PDR) with/without CSME where
             proliferative component has been adequately treated with laser photocoagulation.

        All patients fulfilling criteria 1 with 2 or 3 shall be enrolled in the study. The patients
        of either sex up to the age of 60 years would be included for the study.

        Exclusion Criteria:

        The following would be the exclusion criteria:

          -  Presence of untreated proliferative diabetic retinopathy

          -  Patients with history of ocular hypertension or glaucoma

          -  Presence of associated conditions that may exacerbate macular edema, i.e. uveitis,
             retinal vein occlusions, neovascular glaucoma

          -  History of use of drugs such as prostaglandin analogues, adrenaline or nicotinic acid

          -  Patients with post-operative media haze or pupillary non-dilation that does not allow
             good fundus photography, Fundus Fluorescein Angiography (FFA) and Optical Coherence
             Tomography (OCT).

          -  Patients who develop any intraoperative complication including posterior capsular
             rent, vitreous loss, zonular dehiscence, etc shall be excluded from the study in both
             the groups