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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03707015
Other study ID # 180315
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2017
Est. completion date January 2018

Study information

Verified date October 2018
Source Changhua Christian Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To describe the technique and outcomes of using either inverted or free internal limiting membrane flap in the management of retinal detachment due to paracentral retinal breaks.


Description:

This retrospective observational case series includes nine patients received surgery for retinal detachment due to paracentral retinal breaks developed either from primary rhegmatogenous orgin, or secondary iatrogenic retinal breaks after prior membrane peeling or during surgery for tractional retinal detachment. Either inverted or free internal limiting membrane flaps were inserted in the identified breaks, followed by air fluid exchange and gas tamponade. Visual acuity and structural changes were evaluated.


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date January 2018
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients with retinal detachment and posterior paracentral retinal breaks located within the equator from January 2017 to January 2018

Exclusion Criteria:

- Patient with macular hole

- Patient with other ocular diseases including ocular hypertension, optic nerve atrophy, glaucoma or chronic uveitis

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
San Ni Chen

References & Publications (2)

Chen SN, Hsieh YT, Yang CM. Multiple Free Internal Limiting Membrane Flap Insertion in the Treatment of Macular Hole-Associated Retinal Detachment in High Myopia. Ophthalmologica. 2018;240(3):143-149. doi: 10.1159/000487337. Epub 2018 Jun 6. — View Citation

Chen SN, Yang CM. Inverted Internal Limiting Membrane Insertion for Macular Hole-Associated Retinal Detachment in High Myopia. Am J Ophthalmol. 2016 Feb;162:99-106.e1. doi: 10.1016/j.ajo.2015.11.013. Epub 2015 Nov 12. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary re-attachment rate of retinal detachment re-attachment of retina through examination including fundoscopic exam and optical coherent tomography exam within 3 months postoperatively
Secondary visual acuity visual acuity in logMAR within 3 months postoperatively
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