The effect of injection of a long-acting steroid implant in the eye of patients with diabetic retinopathy undergoing cataract surgery. (Investigator initiated Ozurdex trial)
- Conditions
- Health Condition 1: null- Diabetic patients with non-proliferative diabetic retinopathy with or without macular edemaHealth Condition 2: H258- Other age-related cataract
- Registration Number
- CTRI/2019/05/019407
- Lead Sponsor
- Allergan India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 151
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)
The patients of either sex (age 30 years or more) would be included for the study.
EXCLUSION CRITERIA
The following would be the exclusion criteria:
1 Presence of proliferative diabetic retinopathy
2 Patients with history of ocular hypertension or glaucoma
3Presence of associated conditions that may exacerbate macular edema, i.e. uveitis, retinal vein occlusions, neovascular glaucoma
4History of use of any intravitreal / periocular agents including but not limited to bevacizumab, ranibizumab or steroids (systemic or local) in the past three months.
5History of use of drugs such as prostaglandin analogues, adrenaline or nicotinic acid
6History of any intraocular surgery or laser photocoagulation in the past three months.
7Any history of prior pars plana vitrectomy
8Patients with post-operative media haze or pupillary non-dilation that does not allow good fundus photography, FFA and OCT.
9Patients who develop any intraoperative complication including posterior capsular rent, vitreous loss, zonular dehiscence, etc shall be excluded from the study in both the groups.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method