“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
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
Scientific
Ulucanlar Cad. No: 59 Altindag
Ankara
06230
Türkiye
Study information
| Study design | Retrospective comparative case-controlled study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 objectives | 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(s) | Ethics Committee of Diskapi Training and Research Hospital, 21/04/2014, reference 15/12 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2008 |
| Completion date | 31/12/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 5-10 |
| Key inclusion criteria | All cases were phakic and had serous macular detachment associated with optic disc pits. |
| Key exclusion criteria | Patients with a history of prior Pars plana vitrectomy (PPV) surgery and any corneal pathology. |
| Date of first enrolment | 01/01/2008 |
| Date of final enrolment | 31/07/2015 |
Locations
Countries of recruitment
- Türkiye
Study participating centre
06230
Türkiye
Sponsor information
Hospital/treatment centre
Ulucanlar Cad. No: 59 Altindag
Ankara
06230
Türkiye
"ROR" |
https://ror.org/045d4f586 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/08/2015 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Not 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.
