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)

The effect of sustained release long acting intravitreal dexamethasone implant in patients with non-proliferative diabetic retinopathy undergoing cataract surgery

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/05/019407

Enrollment

150

Registered

2019-05-29

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Diabetic patients with non-proliferative diabetic retinopathy with or without macular edema Health Condition 2: H258- Other age-related cataract

Interventions

Intervention1: Phacoemulsification with IOL implantation: A. Study group: phacoemulsification with IOL implantation with intraoperative intravitreal injection of dexamethasone implant B. Control gro

Eligibility

Inclusion criteria

Inclusion 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) The patients of either sex (age 30 years or more) would be included for the study.

Exclusion criteria

Exclusion criteria: EXCLUSION CRITERIA The following would be the exclusion criteria: 1 Presence of proliferative diabetic retinopathy 2 Patients with history of ocular hypertension or glaucoma 3 Presence of associated conditions that may exacerbate macular edema, i.e. uveitis, retinal vein occlusions, neovascular glaucoma 4 History of use of any intravitreal / periocular agents including but not limited to bevacizumab, ranibizumab or steroids (systemic or local) in the past three months. 5 History of use of drugs such as prostaglandin analogues, adrenaline or nicotinic acid 6 History of any intraocular surgery or laser photocoagulation in the past three months. 7 Any history of prior pars plana vitrectomy 8 Patients with post-operative media haze or pupillary non-dilation that does not allow good fundus photography, FFA and OCT. 9 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.

Design outcomes

Primary

Measure	Time frame
1). Change in the status of background diabetic retinopathy without macular involvement to with macular involvement 2. Central macular thickness, either an increase or decrease or same as measured by optical coherence tomography as compared to the preoperative thickness at 3 month. 3). Change in the postoperative inflammation as measured by flare meter in study versus control group. Timepoint: Day 1, week 1, week 2, week 4 and week 12	—

Measure

Time frame

1). Change in the status of background diabetic retinopathy without macular involvement to with macular involvement 2. Central macular thickness, either an increase or decrease or same as measured by optical coherence tomography as compared to the preoperative thickness at 3 month. 3). Change in the postoperative inflammation as measured by flare meter in study versus control group. Timepoint: Day 1, week 1, week 2, week 4 and week 12

—

Secondary

Measure	Time frame
Change in the visual acuity as measured by the Log MAR visual acuity scale. Timepoint: Day 1, week 1, week 2, week 4 and week 12	—

Countries

India

Contacts

Public ContactJagat Ram

PGIMER, Chandigarh

drjagatram@gmail.com919876081419

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026