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CompletedNCT01307072Updated Aug 2, 2012

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

An observational study in Proliferative Diabetic Retinopathy, sponsored by Kyorin University. Completed at 1 site in Japan. Per ClinicalTrials.gov, last updated 2012-08-02.

Sponsored by Kyorin University · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
94
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Proliferative Diabetic Retinopathy

Keywords

  • periodic examinations, compliance
03

In context

Retinal Diseases

815 studies on the registry are indexed under Retinal Diseases; 105 are open to participants now.

This study's enrollment of 94 is below the median of 180 across 282 observational studies indexed under Retinal Diseases.

Browse Retinal Diseases studies →

Lead sponsor

Kyorin University is the lead sponsor of 33 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

Exclusion Criteria:

  • The patients were not followed more than 6 months.
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
94 participants (actual)

Groups and cohorts

  • Never-treated group

    The patients who had no previous ophthalmic examination until the first visit when vitreous surgery was prescribed

    Procedure: Vitrectomy

  • The non-compliant group

    The patients with a history of missing ophthalmic examination over a one year period

    Procedure: Vitrectomy

  • The compliant group

    The patients who had ophthalmic examinations at least once a year

    Procedure: Vitrectomy

Interventions

  • ProcedureVitrectomy

    Vitrectomy. Diabetic retinopathy

    Also known as: Compliance of follow-up

06

What researchers measure

Primary outcomes

  1. Preoperative status

    Plasma level of glycosylated hemoglobin (HbA1c)

    Time frame: Preoperative period

  2. Preoperative status

    Best-corrected visual acuity (BCVA),

    Time frame: Preoperative period

Secondary outcomes

  1. Postoperative status

    Postoperative best-corrected visual acuity (BCVA) at 6 months and the final examination

    Time frame: up to 1 year

  2. Postoperative status

    Status of the proliferative diabetic retinopathy

    Time frame: up to 1 year

  3. Postoperative status

    Presence of neovascular glaucoma.

    Time frame: up to 1 year

07

Study locations

1 site
  • Kyorin Eye Center
    Mitaka, Tokyo 181-8611, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01307072
Lead sponsor
Kyorin University
Responsible party
Makoto Inoue (Associate professor, Kyorin University) — Principal investigator
First posted
Mar 2, 2011
Start date
Sep 2008
Primary completion
Aug 2009
Completion
Apr 2010
Last update
Aug 2, 2012

Study contacts

Makoto Inoue, MD
principal investigator · Kyorin Eye Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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