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Completed

NCT Number: NCT01307072

Compliance to Ophthalmic Follow-up Examinations and Surgical Outcome 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.

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Key information

Conditions

Proliferative Diabetic Retinopathy Behavior Health Behavior Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Sex eligibility

All sexes

Study type

Observational

Primary location

Kyorin Eye Center

Mitaka, Tokyo, 181-8611, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitrectomy

Procedure

Vitrectomy. Diabetic retinopathy

Other names: Compliance of follow-up

Primary outcomes

  1. Preoperative status

    Time frame: Preoperative period

    Plasma level of glycosylated hemoglobin (HbA1c)

  2. Preoperative status

    Time frame: Preoperative period

    Best-corrected visual acuity (BCVA),

Secondary outcomes

  1. Postoperative status

    Time frame: up to 1 year

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

  2. Postoperative status

    Time frame: up to 1 year

    Status of the proliferative diabetic retinopathy

  3. Postoperative status

    Time frame: up to 1 year

    Presence of neovascular glaucoma.

Sponsors and collaborators

Lead sponsor

Kyorin University

Other

Registry information

Official study title

Compliance to Ophthalmic Follow-up Examinations Affect Outcome of Vitrectomy for Proliferative Diabetic Retinopathy

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Mar 2, 2011
Registry last updated
Aug 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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