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
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Diabetic Macular Edema (DME) and cataract constitute important causes of visual impairment in
      patients with diabetes mellitus. Cataract surgery in patients with diabetic retinopathy is
      associated with progression of both retinopathy and maculopathy in nearly 23-57% of cases,
      thus affecting the final visual outcome. Post-cataract surgery, macular edema may be due to
      worsening/presence of pre-existing clinically significant macular edema (CSME) or due to
      development of Irvine Gass Syndrome where cystoid macular edema (CME) occurs in the post
      operative period and is believed to be inflammatory in origin. Focal/ grid laser
      photocoagulation is the standard of care in the management of CSME, which may be pre-existing
      at the time of cataract surgery or worsens following surgery. Several adjuncts including
      intravitreal corticosteroids, Pegaptanib Sodium (Macugen; Pfizer, New York), Ranibizumab
      (Lucentis; Genentech, South San Francisco, California), Bevacizumab (Avastin, Genentech) have
      been tried in an attempt to improve the visual results.

      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
      edema13. Intravitreal Triamcinolone Acetonide (TA), a water insoluble steroid, has been shown
      to reduce the retinal thickness and improve the visual acuity14-16. However, recurrence of
      macular edema in patients who receive intravitreal TA is a major concern as the patients need
      multiple repeat injections because of the short half life of the drug (18.6 days). A more
      potent steroid, dexamethasone has also been tried as an alternative to TA for macular edema;
      however, its short half life of only 3 hours prevents its clinical application.

      In search for the ideal corticosteroid preparation, a Dexamethasone Posterior Segment Drug
      Delivery System (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. 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.
    

Intervention name(s): Dexamethasone Drug delivery system (Ozurdex); Cataract surgery
Intervention type(s): Drug; Procedure
Intervention description(s): 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.
Other intervention name(s): Ozurdex; Phacoemulsification
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment