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 Kyorin University:

Primary Outcome Measures:
  • Preoperative status [ Time Frame: Preoperative period ] [ Designated as safety issue: No ]
    Plasma level of glycosylated hemoglobin (HbA1c)

  • Preoperative status [ Time Frame: Preoperative period ] [ Designated as safety issue: No ]
    Best-corrected visual acuity (BCVA),


Secondary Outcome Measures:
  • Postoperative status [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    Postoperative best-corrected visual acuity (BCVA) at 6 months and the final examination

  • Postoperative status [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    Status of the proliferative diabetic retinopathy

  • Postoperative status [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    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

Genders Eligible for Study:   Both
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
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

No publications provided

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
Health Authority: Japan: Institutional Review Board

Keywords provided by Kyorin University:
periodic examinations, compliance

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

ClinicalTrials.gov processed this record on April 22, 2014