Condition category
Eye Diseases
Date applied
05/07/2015
Date assigned
22/07/2015
Last edited
04/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Mehmet Citirik

ORCID ID

Contact details

Ulucanlar Cad. No: 59 Altindag
Ankara
06230
Turkey

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 measures

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

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

Sponsor information

Organisation

Ankara Ulucanlar Eye Education and Research Hospital

Sponsor details

Ulucanlar Cad. No: 59 Altindag
Ankara
06230
Turkey

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26209233

Publication citations

Additional files

Editorial Notes

04/11/2015: Publication reference added.