NCT01694212

Brief Summary

Diabetes has many negative effects on patients' general health. Among many other consequences it speeds up the cataract formation and that is why diabetic patients need cataract surgery very often. The known side effect of cataract surgery even in otherwise healthy patients is postoperative edema of the back of the eye (what causes decrease of vision), which has greater incidence especially in patients who have diabetic eye problems. The cause of that might be the intraocular inflammation which was previously demonstrated to be significantly more prominent in patients with untreated diabetic eye problems. Therefore we will examine if the 7 day use of anti-inflammatory eye drops prior to the cataract surgery prevent the formation of the edema of the back of the eye.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 27, 2012

Completed
4 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 20, 2017

Status Verified

April 1, 2017

Enrollment Period

4 years

First QC Date

September 23, 2012

Last Update Submit

April 19, 2017

Conditions

Macular EdemaCataractDiabetic Retinopathy

Keywords

Macular edemaCataractDiabetic retinopathyAnti-inflammatory agents,Non-steroidal

Outcome Measures

Primary Outcomes (1)

  • Change of Central Macular Thickness

    The central macular thickness will be measured with OCT machine.

    -7, 0, 1, 7, 30, 90 days after the cataract surger

Secondary Outcomes (2)

  • progression of diabetic retinopathy

    -7 and 90 days after cataract surgery

  • IL-12 concentration

    immediately before cataract surgery

Study Arms (2)

Diclofenac

EXPERIMENTAL

Patients with diabetic retinopathy having preoperative treatment with diclofenac

Drug: Perioperative Diclofenac eye-drops administration

Placebo

PLACEBO COMPARATOR

Control group having placebo treatment

Drug: placebo

Interventions

Perioperative Diclofenac eye-drops administrationDRUG
Diclofenac
placeboDRUG
Placebo

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • presence of nonproliferative diabetic retinopathy
  • presence of the cataract (LOCS 2-3)

You may not qualify if:

  • other chronic or acute eye diseases
  • hypersensitivity to any component of the diclofenac eye-drops patients on oral anticoagulant therapy
  • allergy to salycilates

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poliklinika Medic Zuljan Jukić

Split, 21000, Croatia

Location

MeSH Terms

Conditions

Macular EdemaCataractDiabetic Retinopathy

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye DiseasesLens DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Ljubo Znaor, MD PhD

    Clinical Hospital Center, Split

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ophthalmologist

Study Record Dates

First Submitted

September 23, 2012

First Posted

September 27, 2012

Study Start

October 1, 2012

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

April 20, 2017

Record last verified: 2017-04

Locations

CR(1)