- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02010138
Extent of ILM Removal and Its Impact on Outcomes of MH Surgery
Extent of Internal Limiting Membrane Removal and Its Impact on Outcomes of Macular Hole Surgery
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This randomized clinical trial was performed at a single center. Patients who were scheduled for surgery for idiopathic macular hole (MH) were enrolled. Eligible patients were equally randomized to small extent group or large extent group depending on the extent of ILM to be removed. Random numbers were generated through computerized block-randomization.
A standard 3-port pars plana vitrectomy was performed by a single surgeon using 23-gauge vitrectomy system, with a 1-step scleral tunnel incision. After posterior vitreous detachment was achieved, peeling of the ILM was performed by an end gripping forceps with the assistance of indocyanine green dye. The ILM was peeled in round shape with the radius of either 0.75-disc diameter or 1.5-disc diameter centering at the center of the MH according to the pre-assigned group. This was followed by a complete fluid-gas exchange, and all patients were encouraged to maintain a face-down position for at least 5 days postoperatively.
Postoperative measurements of BCVA and M-score were conducted at 2- and 6-month follow-up visits by independent masked observers. The first postoperative SD-OCT scanning was usually conducted at 1 to 2 weeks after operation according to the intraocular gas status. Then, OCT scans were conducted at follow-up visits 2, and 6 months postoperatively. The same experienced examiner conducted all the OCT scans on all subjects.
Comparison of anatomical closure, BCVA, M-score, Δ BCVA, and Δ M-score were primarily performed between the two groups. Then, the parameters measured from OCT scans with changes in ETDRS visual acuity and M-score were analyzed.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Seoul, Korea, Republiken av, 06315
- Samsung Medical Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- idiopathic macular hole
Exclusion Criteria:
- macular hole associated with other causative diseases
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Small Extent Group (SG)
Patients who were scheduled for surgery for idiopathic macular hole were randomly assigned to the SG.
The small-extent peeling was performed in SG.
|
The internal limiting membrane was peeled in round shape with the radius of 0.75-disc diameter radius (1.5-disc diameter in total) centering at the center of the macular hole.
|
|
Aktiv komparator: Large Extent Group (LG)
Patients who were scheduled for surgery for idiopathic macular hole were randomly assigned to the LG.
The large-extent peeling was performed in LG.
|
The internal limiting membrane was peeled in round shape with the radius of 1.5-disc diameter radius (3.0-disc diameter in total) centering at the center of the macular hole.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Degree of foveal elongation
Tidsram: postoperative 6months
|
postoperative 6months
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
metamorphopsia
Tidsram: 6months
|
6months
|
Andra resultatmått
Resultatmått |
Tidsram |
|---|---|
|
förändring i synskärpan
Tidsram: 6 månader
|
6 månader
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Kunho Bae, MD, Department of Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2013-07-083
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