Pars Plana Vitrecromy in Patients Aged 85 Years and Above

Age Related Macular Degeneration Clinical Trial

— PPV  

Official title:

Pars Plana Vitrecromy in Patients Aged 85 Years and Above

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03222362
• Other study ID #: 0542-15-TLV
• Status: Completed
• Phase: N/A
• First received: July 16, 2017
• Last updated: July 16, 2017
• Start date: January 1, 2006
• Est. completion date: December 31, 2015

Study information

• Verified date: July 2017
• Source: Tel Aviv Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 31, 2015
• Est. primary completion date: December 31, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 85 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration
• Retinal Detachment
• Vitreous Injury

Intervention

Other:
• Surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel Aviv Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual acuity	visual acuity in Snellen chart	study entry until December 2015 .
Secondary	Postoperative complications	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 .