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

March 1, 2011
July 31, 2012
September 2008
August 2009   (final data collection date for primary outcome measure)
  • 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),
Same as current
Complete list of historical versions of study NCT01307072 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Compliance to Ophthalmic Follow-up Examinations and Surgical Outcome for Proliferative Diabetic Retinopathy
Compliance to Ophthalmic Follow-up Examinations Affect Outcome of Vitrectomy for Proliferative Diabetic Retinopathy

The relationship between the surgical outcome of vitreous surgery for proliferative diabetic retinopathy and the compliance to ophthalmic follow-up examinations was evaluated.

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.

Observational
Observational Model: Case Control
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample

The patients that underwent their first vitreous surgery for proliferaftive diabetic retinopathy

Proliferative Diabetic Retinopathy
Procedure: Vitrectomy
Vitrectomy. Diabetic retinopathy
Other Name: Compliance of follow-up
  • Never-treated group
    The patients who had no previous ophthalmic examination until the first visit when vitreous surgery was prescribed
    Intervention: Procedure: Vitrectomy
  • The non-compliant group
    The patients with a history of missing ophthalmic examination over a one year period
    Intervention: Procedure: Vitrectomy
  • The compliant group
    The patients who had ophthalmic examinations at least once a year
    Intervention: Procedure: Vitrectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
94
April 2010
August 2009   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01307072
Kyorineye003
No
Makoto Inoue, Kyorin University
Kyorin University
Not Provided
Principal Investigator: Makoto Inoue, MD Kyorin Eye Center
Kyorin University
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP