Pars Plana Vitrecromy in Patients Aged 85 Years and Above

NCT ID: NCT03222362

Last Updated: 2017-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-01

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vitreous Injury Retinal Detachment Age Related Macular Degeneration

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Surgery

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Surgery

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tel Aviv Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Adiel Barak

Head Of vitrerretinal service

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0542-15-TLV

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.