Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-25 @ 3:56 AM
NCT ID:
NCT01546402
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
70 Years
Study:
NCT01546402
Study Brief:
Protocol Section:
NCT01546402