The effect of enoxaparin-containing irrigation fluid during cataract surgery on post-operative inflammation in patients with diabetes

The effect of enoxaparin-containing irrigation fluid during cataract surgery on post-operative inflammation in patients with diabetes; a randomized controlled clinical trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000775718

Enrollment

Registered

2013-07-11

Start date

2010-08-11

Completion date

2012-08-23

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of the study is to determine if intraocular infusion of low-molecular weight (enoxaparin) influences post-operative inflammation following cataract surgery in patients with diabetes

Interventions

Arm 1; Drug: Enoxaparin. It is administered during the cataract surgery. The mode of the administration is intraocular infusion. Enoxaparin 40 mg/500 ml in Balanced Salt Solution Other name: clexane (Aventis)

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

The study included non-insulin-dependent diabetes mellitus (NIDDM) patients that had moderate non-proliferative diabetic retinopathy (NPDR) according to Early Treatment Diabetic Retinopathy Study (ETDRS) and had grade 2-3 nuclear cataracts based on the classification of Lens Opacity Classification System III (LOCS III)

Exclusion criteria

Patients who underwent laser photocoagulation in the previous three months and patients with small pupils, posterior synechia and history of uveitis were excluded from the study

Outcome results