This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Compliance to Ophthalmic Follow-up Examinations and Surgical Outcome for Proliferative Diabetic Retinopathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Makoto Inoue, Kyorin University
ClinicalTrials.gov Identifier:
NCT01307072
First received: March 1, 2011
Last updated: July 31, 2012
Last verified: July 2012
  Purpose
The relationship between the surgical outcome of vitreous surgery for proliferative diabetic retinopathy and the compliance to ophthalmic follow-up examinations was evaluated.

Condition Intervention
Proliferative Diabetic Retinopathy Procedure: Vitrectomy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Compliance to Ophthalmic Follow-up Examinations Affect Outcome of Vitrectomy for Proliferative Diabetic Retinopathy

Resource links provided by NLM:


Further study details as provided by Makoto Inoue, Kyorin University:

Primary Outcome Measures:
  • Preoperative status [ Time Frame: Preoperative period ]
    Plasma level of glycosylated hemoglobin (HbA1c)

  • Preoperative status [ Time Frame: Preoperative period ]
    Best-corrected visual acuity (BCVA),


Secondary Outcome Measures:
  • Postoperative status [ Time Frame: up to 1 year ]
    Postoperative best-corrected visual acuity (BCVA) at 6 months and the final examination

  • Postoperative status [ Time Frame: up to 1 year ]
    Status of the proliferative diabetic retinopathy

  • Postoperative status [ Time Frame: up to 1 year ]
    Presence of neovascular glaucoma.


Enrollment: 94
Study Start Date: September 2008
Study Completion Date: April 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Never-treated group
The patients who had no previous ophthalmic examination until the first visit when vitreous surgery was prescribed
Procedure: Vitrectomy
Vitrectomy. Diabetic retinopathy
Other Name: Compliance of follow-up
The non-compliant group
The patients with a history of missing ophthalmic examination over a one year period
Procedure: Vitrectomy
Vitrectomy. Diabetic retinopathy
Other Name: Compliance of follow-up
The compliant group
The patients who had ophthalmic examinations at least once a year
Procedure: Vitrectomy
Vitrectomy. Diabetic retinopathy
Other Name: Compliance of follow-up

Detailed Description:
The medical records of 94 patients that had undergone vitreous surgery for proliferative diabetic retinopathy (PDR) and were followed for at least 6 months were reviewed. The subjects were divided into three groups; the never-treated group consisting of patients who had no previous ophthalmic examination until the first visit when vitreous surgery was prescribed; the non-compliant group consisting of patients with a history of missing ophthalmic examination over a one year period, and the compliant group consisting of patients who had ophthalmic examinations at least once a year. The evaluations included age, gender, plasma level of glycosylated hemoglobin (HbA1c) at the preoperative examination, presence of preoperative panretinal photocoagulation, preoperative best-corrected visual acuity (BCVA), postoperative BCVA at the final examination, status of the PDR, the numbers of vitreous surgeries, and presence of pre- and postoperative neovascular glaucoma.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The patients that underwent their first vitreous surgery for proliferaftive diabetic retinopathy
Criteria

Inclusion Criteria:

  • One hundred and twenty-eight eyes of 94 patients that had undergone vitreous surgery for proliferative diabetic retinopathy.
  • Type 2 diabetes.

Exclusion Criteria:

  • The patients were not followed more than 6 months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01307072

Locations
Japan
Kyorin Eye Center
Mitaka, Tokyo, Japan, 181-8611
Sponsors and Collaborators
Kyorin University
Investigators
Principal Investigator: Makoto Inoue, MD Kyorin Eye Center
  More Information

Responsible Party: Makoto Inoue, Associate professor, Kyorin University
ClinicalTrials.gov Identifier: NCT01307072     History of Changes
Other Study ID Numbers: Kyorineye003
Study First Received: March 1, 2011
Last Updated: July 31, 2012

Keywords provided by Makoto Inoue, Kyorin University:
periodic examinations, compliance

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 23, 2017