“23-Gauge Vitrectomy, Endolaser, and Gas Tamponade” versus “Vitrectomy alone” for the Management of ‘Serous Macular Detachment Associated with Optic Disc Pit’

ISRCTN ISRCTN13759180
DOI https://doi.org/10.1186/ISRCTN13759180
Secondary identifying numbers N/A
Submission date
05/07/2015
Registration date
22/07/2015
Last edited
04/11/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Mehmet Citirik
Scientific

Ulucanlar Cad. No: 59 Altindag
Ankara
06230
Türkiye

Study information

Study designRetrospective comparative case-controlled study
Primary study designObservational
Secondary study designCase-control study
Study setting(s)Hospital
Study typeTreatment
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.
Study objectivesAre 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(s)Ethics Committee of Diskapi Training and Research Hospital, 21/04/2014, reference 15/12
Health condition(s) or problem(s) studiedOptic disc pits (rare congenital anomaly with a reported incidence of one in 11,000 patients)
InterventionSome 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 typeOther
Primary outcome measureDifferences 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 measuresDifferences in the mean time of the subretinal fluid resolution between the two groups.
Overall study start date01/01/2008
Completion date31/12/2015

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants5-10
Key inclusion criteriaAll cases were phakic and had serous macular detachment associated with optic disc pits.
Key exclusion criteriaPatients with a history of prior Pars plana vitrectomy (PPV) surgery and any corneal pathology.
Date of first enrolment01/01/2008
Date of final enrolment31/07/2015

Locations

Countries of recruitment

  • Türkiye

Study participating centre

Ankara Ulucanlar Eye Education and Research Hospital
Ankara
06230
Türkiye

Sponsor information

Ankara Ulucanlar Eye Education and Research Hospital
Hospital/treatment centre

Ulucanlar Cad. No: 59 Altindag
Ankara
06230
Türkiye

ROR logo "ROR" https://ror.org/045d4f586

Funders

Funder type

Hospital/treatment centre

Ankara Ulucanlar Eye Education and Research Hospital

No information available

Results and Publications

Intention to publish date01/08/2015
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/10/2015 Yes No

Editorial Notes

04/11/2015: Publication reference added.