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A trial to compare the outcomes of new lens having heparin coated surface with currently being used lens(without heparin coating) in diabetic patients with cataract

Phase 4
Conditions
Health Condition 1: null- diabetic patient with cataract admitted for cataract surgery(phacoimulsification) with intraoccular lens(IOL) implantation.
Registration Number
CTRI/2016/02/006624
Lead Sponsor
AIIMS
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
100
Inclusion Criteria

1 Diabetes mellitus

2 Age â?? 45 years or above

3 Presence of cataract sufficient to cause visual symptoms in patients with diabetes mellitus requiring medical control

4 Patients with no evidence of diabetic retinopathy or mild to moderate non proliferative diabetic retinopathy without maculopathy

5 Patient willing to give informed consent

6 Patients willing to come for follow ups

Exclusion Criteria

Presence of coexistent ocular disease likely to modify visual acuity other than diabetic retinopathy (eg, age-related macular degeneration, amblyopia, or retinal venous occlusion)

Proliferative or very severe non proliferative diabetic retinopathy and clinically significant macular edema

Iris neovascularization

Prior intraocular surgery (eg, trabeculectomy or vitrectomy

Intraocular tumors

Pseudoexfoliation syndrome

Intraoperative capsule complications such as anterior or posterior capsule tears

Use of oral steroids or glaucoma medications

Patients not giving consent for the study

Patients not willing for follow up

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Comparison of aqueous cell flare <br/ ><br>Macular thickness by spectral domain OCTTimepoint: preoperatively and post operative day 1,day 7,day 14, day 21, day 28 ,2 months 3 month ,6 month ,one year
Secondary Outcome Measures
NameTimeMethod
Visual acuity(uncorrected and best corrected) <br/ ><br>Intraocular pressure <br/ ><br>Posterior capsule status <br/ ><br>Intraocular lens position and surface <br/ ><br>Fundus evaluationTimepoint: preoperatively and post operative day 1,day 7,day 14, day 21, day 28 ,2 months 3 month ,6 month ,one year
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