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Hole Closure in Vitrectomy with internal limiting membrane repositioning and autologous blood for Macular hole retinal detachment repair in High myopes

Hole Closure in Vitrectomy with internal limiting membrane repositioning and autologous blood for Macular hole retinal detachment repair in High myopes

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001342404
Enrollment
30
Registered
2016-09-26
Start date
2016-06-13
Completion date
2017-12-31
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Methods: This study is a prospective cohort study Institution: Hong Kong Eye Hospital The purpose of this study is to evaluate the reconstructive process of anatomical hole closure and functional outcomes of a novel surgical strategy- vitrectomy with inverted internal limiting membrane (ILM) repositioning and autologous blood clot for macular hole retinal detachment (MHRD) in highly myopic eyes. No prospective study has been done so far, and this study can provide new data on microstructural imaging analysis of hole closure by optical coherence tomography (OCT) imaging and functional outcomes of the above surgical technique, can increase understanding of the process and mechanisms of macular hole closure in MHRD in highly myopic eyes, and fill the gap in the literature.

Interventions

Prospective interventional cohort study of 30 eyes of 30 consecutive patients with high myopia and MHRD if they satisfy the inclusion and exclusion criteria, will be invited to join the study and if they agree, will sign the consent form. Best-corrected visual acuity, refraction, slit lamp examination, lens status, intraocular pressure, fundus examination, fundus photo, axial length and optical coherence tomography findings will be documented before surgery. All patients will be operated unde

Prospective interventional cohort study of 30 eyes of 30 consecutive patients with high myopia and MHRD if they satisfy the inclusion and exclusion criteria, will be invited to join the study and if they agree, will sign the consent form. Best-corrected visual acuity, refraction, slit lamp examination, lens status, intraocular pressure, fundus examination, fundus photo, axial length and optical coherence tomography findings will be documented before surgery. All patients will be operated under regional or general anaesthesia by the investigators. Combined cataract surgery and intraocular lens implantation will be done when indicated. Standard 3-port 23G vitrectomy followed by Internal limiting membrane (ILM) peeling with ILM Blue and with remnants at the hole edge for creation of an ILM clump repositioned into the macular hole. Fresh blood will be obtained from the patient’s antecubital vein, and injected gently to cover the macular hole. The fresh blood will soon become a clot on the surface of the repositioned ILM filling the macular hole, and seal it. Air-fluid exchange will be done without intentional drainage of subretinal fluid through the macular hole. In cases of extensive retinal detachment extending well beyond the vascular arcades, an extramacular retinotomy may be created at the discretion of the investigator to drain subretinal fluid to facilitate further procedures such as laser photocoagulation. Gas-air exchange will be performed with gas tamponade by 12-14% C3F8 at the end of surgery. Postoperatively, the patients will be asked to remain in a prone position for 3 days and to avoid the supine position afterward during the follow-up period until the gas is absorbed. Procedure is performed by an experienced vitreoretinal surgeon. The approximate duration of the procedure is about 90 minutes.

Sponsors

Kowloon Central Cluster Grant
Lead SponsorGovernment body

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Patients with macular hole retinal detachment (MHRD) with highly myopic eyes (defined as greater than or equal to 6D diopters or axial length greater than or equal to 26.5mm) 2. Age more than 18 years old

Exclusion criteria

1. History of retinal detachment (RD) or proliferative vitreoretinopathy (PVR) 2. History of intraocular surgery, with the exception of retinal laser photocoagulation or peripheral iridotomy, and cataract surgery 3. Macular hole secondary to other causes 4. Diabetic retinopathy, vitreous haemorrhage, retinal vascular occlusion, uveitis, trauma, optic atrophy, glaucoma, or corneal opacity. 5. Patients who cannot comply with any facedown positioning

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026