Plain English Summary
Background and study aims
This is an observational study. The aim is to compare a ‘23-gauge pars plana vitrectomy (PPV), endolaser, and gas tamponade’ approach versus a ‘vitrectomy alone’ for the management of serous macular detachment associated with optic disc pits. We want to find out about the following questions: Are there differences in the postoperative visual acuity and the postoperative central foveal thickness between two groups? What is the mean time of the postoperative subretinal fluid resolution in both groups? Is there correlation between the preoperative features of the inner/outer segment junction with improvement of postoperative visual acuity?
We would like to show that there a difference between the vitrectomy alone and the combined surgery.
Who can participate?
Patients with Phakic intraocular lens (a special kind of lens) and erous macular detachment associated with optic disc pits.
What does the study involve?
All participants undergo a complete ophthalmological examination - visual acuity, intraocular pressure with applanation tonometry, biomicroscobic examination findings, dilated pupil examination of the posterior segment, optic coherence tomography (OCT), and fundus autofluorescence done – a the begininf were evaluated at baseline and during follow-up period.
Some participants have the 23-gauge PPV, endolaser, and gas tamponade procedure, while others only have the 23-gauge PPV procedure.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Ankara Ulucanlar Eye Education and Research Hospital (Turkey)
When is the study starting and how long is it expected to run for?
January 2008 to December 2015.
Who is funding the study?
Ankara Ulucanlar Eye Education and Research Hospital (Turkey)
Who is the main contact?
Dr Mehmet Citirik
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
“23-Gauge Vitrectomy, Endolaser, and Gas Tamponade” versus “Vitrectomy alone” for the Management of ‘Serous Macular Detachment Associated with Optic Disc Pit’: a comparative case control study.
Acronym
Study hypothesis
Are there differences between the clinical outcomes of “23-gauge vitrectomy, endolaser, and gas tamponade” versus “vitrectomy alone” for the management of serous macular detachment associated with optic disc pits?
Ethics approval
Ethics Committee of Diskapi Training and Research Hospital, 21/04/2014, reference 15/12
Study design
Retrospective comparative case-controlled study
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Optic disc pits (rare congenital anomaly with a reported incidence of one in 11,000 patients)
Intervention
Some eyes underwent 23-gauge PPV, endolaser, and gas tamponade (allocated to Group 1) and some eyes of underwent 23-gauge vitrectomy alone (allocated to Group 2). Consecutive cases underwent combined surgery and other consecutive cases underwent vitrectomy alone. All cases were phakic and had serous retinal detachment.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Differences in the postoperative visual acuity and the postoperative central foveal thickness between the two groups.
The main outcome measure was change in best-corrected visual acuity and correlation between best-corrected visual acuity and spectral-domain optical coherence tomography.
Secondary outcome measures
Differences in the mean time of the subretinal fluid resolution between the two groups.
Overall trial start date
01/01/2008
Overall trial end date
31/12/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All cases were phakic and had serous macular detachment associated with optic disc pits.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
5-10
Participant exclusion criteria
Patients with a history of prior Pars plana vitrectomy (PPV) surgery and any corneal pathology.
Recruitment start date
01/01/2008
Recruitment end date
31/07/2015
Locations
Countries of recruitment
Turkey
Trial participating centre
Ankara Ulucanlar Eye Education and Research Hospital
Ankara
06230
Turkey
Funders
Funder type
Hospital/treatment centre
Funder name
Ankara Ulucanlar Eye Education and Research Hospital
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
01/08/2015
Participant level data
Available on request
Basic results (scientific)
Publication list
2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26209233