NCT Number: NCT03222362
Pars Plana Vitrecromy in Patients Aged 85 Years and Above
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.
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Notify MeKey information
Conditions
Age range
85 year and older
Sex eligibility
All sexes
Study type
Observational
About this study
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).
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
visual acuity
Time frame: study entry until December 2015 .
visual acuity in Snellen chart
Secondary outcomes
-
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
Sponsors and collaborators
Lead sponsor
Tel Aviv Medical Center
Other
Registry information
Acronym: PPV
Important dates
- Study start
- 2006
- Primary completion
- 2013
- Study completion
- 2015
- First posted
- Jul 19, 2017
- Registry last updated
- Jul 19, 2017
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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