Pars Plana Vitrecromy in Patients Aged 85 Years and Above (PPV)

July 16, 2017 updated by: Adiel Barak, Tel Aviv Medical Center
We reviewed the records of 120 consecutive patients (male and female), aged 85 years and above, who underwent pars plana vitrecromy in the Tel Aviv Medical Center during the years 01/01/2006 - 31/12/2013, and were followed by physicians in the ophthalmology department in the center until December 2015.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We reviewed the records of 120 consecutive patients (male and female), aged 85 years and above, who underwent pars plana vitrecromy in the Tel Aviv Medical Center during the years 01/01/2006 - 31/12/2013, and were followed by physicians in the ophthalmology department in the center until December 2015. We will be measuring visual acuity, intra-ocular pressure, demographics (age, gender), indication for surgery, ocular co-morbidities, surgical parameters (time of surgery, type of anesthesia - general or local, type of suture), and intraoperative and postoperative complications.

Primary outcome - visual acuity will be measured at base line, after 1 week, 1 month, 3 months, 6 months / last follow up (until December 2015). visual acuity will be determined by a standardized chart test (Snellen chart). For statistical analysis, all VA values were converted to logMAR scale. According to Holladay and the University of Freiburg study group results, blindness was set at 0.00125/2.9 (decimal/logMAR), light perception at 0.0025/2.6, hand movements at 0.005/2.3 and counting fingers at 0.014/1.85. Data will be analyzed using SPSS software. A p-value of 0.05 will be considered statistically significant and t-tests analysis will be used to compare between means.

Secondary outcomes - demographics, Indication for surgery, ocular co morbidities will be measured at baseline. Surgical parameters and intraoperative complications will be measured at 1 week. Postoperative complications will be measured during follow up after 1 week, 1 month, 3 months, 6 months / last follow up (until December 2015).

Complications will be measured by examination of intraocular pressure, slit-lamp and fundus (Ophthalmoscopic Exam).

Study Type

Observational

Enrollment (Actual)

120

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

85 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients aged 85 years and above, who underwent pars plana vitrecromy in the Tel Aviv Medical Center during the years 01/01/2006 - 31/12/2013

Description

Inclusion Criteria:

Patients aged 85 years and above, who underwent pars plana vitrecromy in the Tel Aviv Medical Center during the years 01/01/2006 - 31/12/2013

Exclusion Criteria:

ANy other

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients 85 years and above
120 consecutive patients (male and female), aged 85 years and above, who underwent pars plana vitrecromy in the Tel Aviv Medical Center during the years 01/01/2006 - 31/12/2013, and were followed by physicians in the ophthalmology department in the center until December 2015.
Other: Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual acuity
Time Frame: study entry until December 2015 .
visual acuity in Snellen chart
study entry until December 2015 .

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: study entry until December 2015 .
Postoperative complications will be measured during follow up after 1 week, 1 month, 3 months, 6 months / last follow up
study entry until December 2015 .

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel Aviv Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2006

Primary Completion (Actual)

December 31, 2013

Study Completion (Actual)

December 31, 2015

Study Registration Dates

First Submitted

July 16, 2017

First Submitted That Met QC Criteria

July 16, 2017

First Posted (Actual)

July 19, 2017

Study Record Updates

Last Update Posted (Actual)

July 19, 2017

Last Update Submitted That Met QC Criteria

July 16, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0542-15-TLV

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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