Intraoperative Dexamethasone Implant Improves Outcome of Cataract Surgery With Diabetic Macular Edema

NCT01546402 | Completed Phase 4 Results

• 1 other identifier: aniruddha9
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Macular Edema, Cystoid; Vision Disorders; Diabetic Macular Edema; Cystoid Macular Edema Following Cataract Surgery; Cataract

Outcome Measures

Primary Outcomes (1)

• Change in the Central Macular Thickness

  The primary outcome is the change in the central macular thickness, either an increase or decrease, as measured by optical coherence tomography as compared to the preoperative thickness.

  Baseline and 6 MONTHS

Secondary Outcomes (1)

• Change in the Visual Acuity

  Difference in number of letters read (6 months minus baseline)

Study Arms (2)

Phacoemulsification with IOL implant

EXPERIMENTAL

This group (Group B) includes patients who will undergo phacoemulsification with intraocular lens implantation. The dexamethasone implant will not be injected at the beginning of cataract surgery. 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.

Procedure: Cataract surgery

Phacoemulsification with Ozurdex

EXPERIMENTAL

This group (Group A) includes patients who will undergo phacoemulsification with intraocular lens implantation with intraoperative long acting steroid injection (Ozurdex ®). The dexamethasone implant will be injected at the beginning of cataract surgery, 4mm from the limbus using the specially designed injector. 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.

Drug: Dexamethasone Drug delivery system (Ozurdex)

Interventions

Dexamethasone Drug delivery system (Ozurdex) DRUG

It is a sustained release intravitreal implant containing 700µg dexamethasone has been approved by the US-FDA (Food and Drug Administration).

Also known as: Ozurdex

Phacoemulsification with Ozurdex

Cataract surgery PROCEDURE

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.

Also known as: Phacoemulsification

Phacoemulsification with IOL implant

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of visually significant cataract requiring surgery (any grade)
• Patients with Non-proliferative Diabetic Retinopathy (NPDR) with/without clinically significant macular edema (CSME)
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Postgraduate Institute of Medical Education and Research

Chandigarh, Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Macular Edema; Vision Disorders; Cataract

Interventions

Calcium Dobesilate; Cataract Extraction; Phacoemulsification

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lens Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Ultrasonic Surgical Procedures

Results Point of Contact

• Title: Aniruddha Agarwal
• Organization: Post Graduate Institute of Medical Education and Research

aniruddha9@gmail.com

+911722756111

Study Officials

• Vishali R Gupta, MBBS MS

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

• ANIRUDDHA K AGARWAL, MBBS

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

• Jagat Ram, MBBS MS

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

• Amod Gupta, MBBS MS

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MBBS

Study Record Dates

• First Submitted: March 2, 2012
• First Posted: March 7, 2012
• Study Start: May 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: June 18, 2014
• Results First Posted: June 18, 2014

Record last verified: 2014-06

Locations

IN (1)