Study Results
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.
COMPLETED
47 participants
OBSERVATIONAL
2020-12-01
2020-12-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Influence of Posterior Vitreous Detachment on Retinal Detachment After Lens Surgery in Myopic Eyes
NCT03152747
Pars Plana Vitrectomy Combined With Phacoemulsification Cataract Surgery in Phakic Diabetes Retinopathy Patients
NCT04729023
Partial Posterior Hyaloidectomy in Macular Surgery
NCT01454466
Perfluorocarbon Liquid vs. Posterior Retinotomy During Pars-plana Vitrectomy for Rhegmatogenous Retinal Detachment
NCT06919211
Outcomes of 20 and 23-gauge Combined Transconjunctival Pars Plana Vitrectomy
NCT01176331
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Patient eligibility Patients who underwent uncomplicated cataract surgery with phacoemulsification and in-the-bag IOL implantation and subsequent neodymium:yttrium-aluminum-garnet (Nd:YAG) laser due to capsular opacification were included. Preoperative refractive data obtained after Nd:YAG laser and six months prior to vitrectomy surgery. Postoperative refractive data was obtained at 12 months after vitrectomy. Eyes with a preoperative spherical refractive error \> ±6 D or cylindrical refractive error \> ±3 D were excluded. Also eyes with corneal disorders were excluded.
Ocular parameters
All patients underwent complete ophtalmic examination including best corrected visual acuity (BCVA) in the logMAR scale, slit-lamp examination, intraocular pressure (IOP) assessment, fundus examination and autokeratorefractometry (auto kerato-refractometer KR-8800 from Topcon, Tokyo, Japan) at preoperative and postoperative month-12. Induced astigmatism values were calculated through vector analysis.
Surgical procedures
All surgeries were performed by the same surgeon (S.Y.). Retrobulbar block anesthesia (a mixture of 2 ml of lidocaine hydrochloride 2% and 2 ml of bupivacaine hydrochloride 0.5%) was used. Three port 23-gauge (G) transconjunctival PPV was performed using the vitrectomy system DORC (Dutch Ophthalmic Research Center, Zuidland, Netherlands) and Zeiss microscope with EIBOS 2 (Haag Streit, Mason, OH, USA) attachment for non-contact fundus viewing.
In group 1, all patients underwent a near-complete vitrectomy including base shaving, laser endo-photocoagulation and C3F8 gas tamponade. In group 2, patients with ERM received a limited vitrectomy including; core vitrectomy, induction of a posterior vitreous detachment if not present and peeling of the ERM and inner limiting membrane (ILM). Peripheral retina was examined with indentation to identify any retinal breaks. Neither laser endo-photocoagulation, nor gas tamponade and vitreous base shaving was performed. For patients with VH patients, a near-complete vitrectomy, including base shaving, laser endo-photocoagulation was performed except for gas tamponade. In both groups, the sclera is sutured with 8-0 polyglactin suture (Vicryl) in case of wound leakage.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group
27 patients, Group 1 consisted of patients with pseudophakic rhegmatogoneous retinal detachment who underwent pars plana vitrectomy and 12% perflouropropane (C3F8) gas tamponade and 20 patients Group 2 consisted of patients with epiretinal membrane or vitreous hemorrhage who underwent PPV without any tamponade
pars plana vitrectomy
23 gauge pars plana vitrectomy was performed for retinal detachment, vitreous hemorrhage or epiretinal membrane
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
pars plana vitrectomy
23 gauge pars plana vitrectomy was performed for retinal detachment, vitreous hemorrhage or epiretinal membrane
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Pseudophakic patients who underwent pars plana vitrectomy
Exclusion Criteria
* Patients with a spherical refractive error \> ±6 D
* Patients with a cylindrical refractive error \> ±3 D
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bursa Retina Eye Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
sami yilmaz
Medical doctor, ophthalmology specialist
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sami Yılmaz, MD
Role: PRINCIPAL_INVESTIGATOR
Bursa Retina Eye Hospital
Remzi Avcı, Professor
Role: STUDY_DIRECTOR
Bursa Retina Eye Hospital
Aysegul Mavi Yıldız, MD
Role: PRINCIPAL_INVESTIGATOR
Bursa Retina Eye Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Retina Eye Hospital
Bursa, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Hamoudi H, Kofod M, La Cour M. Refractive change after vitrectomy for epiretinal membrane in pseudophakic eyes. Acta Ophthalmol. 2013 Aug;91(5):434-6. doi: 10.1111/j.1755-3768.2012.02574.x. Epub 2012 Sep 23.
Byrne S, Ng J, Hildreth A, Danjoux JP, Steel DH. Refractive change following pseudophakic vitrectomy. BMC Ophthalmol. 2008 Oct 13;8:19. doi: 10.1186/1471-2415-8-19.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BursaRetinaEyeH
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.