Compliance to Ophthalmic Follow-up Examinations and Surgical Outcome for Proliferative Diabetic Retinopathy
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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 |
- 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),
- 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 |
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:
- The patients were not followed more than 6 months.
Contacts and Locations
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 May 16, 2013