CClinicalTrials.gg
Status unknownNCT03551808Updated Jun 11, 2018

Prophylactic Effect of Ketorolac Tromethamine on the Cystoid Macular Edema After Phacoemulsification in Diabetic Patients

A Phase 2 interventional study of using of Ketorolac Tromethamine Eye Drop in Cystoid Macular Edema After Phacoemulsification, sponsored by Shahid Beheshti University of Medical Sciences. Status unknown at 1 site in Iran, Islamic Republic of. Open to participants aged 20 Years to 95 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-11.

Sponsored by Shahid Beheshti University of Medical Sciences · Phase 2, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Apr 2018), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Jan 2017, registered Apr 2018).
Phase
Phase 2
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
20 Years to 95 Years
Sex
All
01

Study summary

The aim of the study is determining the prophylactic effect of ketorolac tromethamine drop 0.5% eye drop on the functional and anatomical ocular characteristics of the diabetic patients after the phacoemulsification surgery. Cystoid macular edema (CME) is a ocular disease which the retinal thickness is increased by 30 % incidence at least or the visual acuity is decreased to 20/40 according to clinical definition. Ketorolac tromethamine is an non steroidal anti inflammatory medication which is used for treatment and Prophylactic for CME. Teh aim of this study is prophylactic effect of ketorolac tromethamine on choroidal and retinal thickness after Phacoemulsification in Diabetic Patients. In this randomized clinical trial, 102 eyes of 102 diabetic patients were included. All patients were undergone phacoemulsification surgery at Torfeh Eye Hospital between September 2015 and January 2017. To evaluate the prophylactic effect of ketorolac tromethamine topical eye drop, all cases were asked to apply it one day before the s:surgery in each 8 hours and continue it for 4 weeks after the surgery. Controls were not received placebo. All study population were examined using Snellen visual acuity chart, enhanced depth imaging optical coherence tomography (EDI-OCT). All patients were followed at 6, 12 and 24 weeks after the cataract surgery.

02

Conditions studied

  • Cystoid Macular Edema After Phacoemulsification
03

In context

Macular Edema

841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.

This study's planned enrollment of 102 is above the median of 50 across 619 interventional studies indexed under Macular Edema.

Browse Macular Edema studies →

Lead sponsor

Shahid Beheshti University of Medical Sciences is the lead sponsor of 221 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Diabetic patients (type II) with cataract
  • Eligible patients at age range of 20 to 95 years old

Exclusion criteria

Exclusion Criteria:

  • Cases with a diabetic macular edema
  • proliferative diabetic retinopathy
  • history of intravitreal injection of bevacizumab and macular photocoagulation prior three months to the cataract surgery
  • glaucoma
  • refractive errors of more than ±6 diopters
  • history of previous ocular surgery
  • ocular pathological disorders
  • history of systemic diseases
  • history of medications which have a side effect on the retinal thickness
  • patients with a follow up of less than 6 months
  • individuals with any intraoperative complications will be excluded from this study.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
102 participants (estimated)

Study arms

  • Active comparator
    installation of Ketorolac Tromethamine Eye Drop

    Drug: using of Ketorolac Tromethamine Eye Drop

  • No intervention
    not receiving placebo

Interventions

  • Drugusing of Ketorolac Tromethamine Eye Drop

    using of Ketorolac Tromethamine Eye Drop one day before the surgery in each 8 hours and continue it for 4 weeks after the surgery

06

What researchers measure

Primary outcomes

  1. Best Corrected visual acuity

    Snellen visual acuity chart

    Time frame: 24 weeks after the surgery

Secondary outcomes

  1. retinal and choroidal thickness

    enhanced depth imaging optical coherence tomography (EDI-OCT)

    Time frame: 24 weeks after the surgery

07

Study locations

1 of 1 sites recruiting
  • Tehran, Iran, Islamic Republic of
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03551808
Lead sponsor
Shahid Beheshti University of Medical Sciences
Responsible party
Zahra Rabbani Khah (Clinical Professor, Shahid Beheshti University of Medical Sciences) — Principal investigator
First posted
Jun 11, 2018
Start date
Jan 1, 2017
Primary completion
Jun 1, 2017
Completion
Jun 1, 2018 (estimated)
Last update
Jun 11, 2018

Study contacts

Hossien Mohammad Rabie, MD
Contact
labbafi@hotmail.com
9822591616

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion