NCT02464800

Brief Summary

The medical records of 393 eyes of 326 patients with severe proliferative diabetic retinopathy were reviewed. Higher cutting rate instruments (5000 cut per minute) were used in 174 eyes and conventional instruments in 219 eyes (2500 cut per minute). The visual outcome and incidences of intraoperative and postoperative complications were compared.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
326

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2007

Longer than P75 for all trials

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

Study Start

First participant enrolled

April 1, 2007

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 8, 2015

Completed
Last Updated

June 8, 2015

Status Verified

June 1, 2015

Enrollment Period

6.9 years

First QC Date

June 2, 2015

Last Update Submit

June 3, 2015

Conditions

Proliferative Diabetic Retinopathy

Keywords

diabetic retinopathy

Outcome Measures

Primary Outcomes (1)

  • Visual acuity

    6 months

Secondary Outcomes (1)

  • Retinal reattachment

    6 months

Study Arms (2)

Higher cutting rate group

Vitrectomy with higher cutting rate instruments (5000 cut per minute) were performed in 174 eyes for proliferative diabetic retinopathy

Procedure: Vitrectomy for proliferative diabetic retinopathy

Conventional cutting rate group

Vitrectomy with conventional instruments (2500 cut per minute) were performed in 219 eyes for proliferative diabetic retinopathy

Procedure: Vitrectomy for proliferative diabetic retinopathy

Interventions

Vitrectomy for proliferative diabetic retinopathyPROCEDURE

25-gauge vitrectomy

Conventional cutting rate groupHigher cutting rate group

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients who underwent 25-gauge vitrectomy for proliferative diabetic retinopathy with higher cutting rate instruments or conventional instruments

You may not qualify if:

  • The eyes with follow-up less than 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Makoto Inoue

Mitaka, Tokyo, 181-8611, Japan

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Vitrectomy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Kyorin Eye center

Study Record Dates

First Submitted

June 2, 2015

First Posted

June 8, 2015

Study Start

April 1, 2007

Primary Completion

March 1, 2014

Study Completion

March 1, 2015

Last Updated

June 8, 2015

Record last verified: 2015-06

Locations

JP(1)