CompletedPhase 4

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

India20 participantsStarted 2011-05

Plain-language 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.

Who can participate

Age range

35 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in the Central Macular Thickness

Timeframe: Baseline and 6 MONTHS

Trial details

NCT IDNCT01546402

SponsorPost Graduate Institute of Medical Education and Research, Chandigarh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-11

Results submitted2014-04-15

View on ClinicalTrials.gov More Macular Edema, Cystoid trials