RecruitingACTRN12616001342404

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


Sponsor

Kowloon Central Cluster Grant

Enrollment

30 participants

Start Date

Jun 13, 2016

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at whether a new surgical technique — using a folded membrane from inside the eye (inverted ILM) and a small drop of blood — can reliably repair a condition called macular hole retinal detachment in people with severe short-sightedness (high myopia). This combination approach is being tracked with high-resolution eye imaging to understand how the hole heals. You may be eligible if: - You are 18 years of age or older - You have been diagnosed with macular hole retinal detachment - You have high myopia (prescription of -6 diopters or more, or eye length of 26.5 mm or more) You may NOT be eligible if: - You have had a previous retinal detachment or vitreoretinopathy - You have had previous eye surgery (other than laser, peripheral iridotomy, or cataract surgery) - You have other eye conditions such as diabetic retinopathy, glaucoma, or uveitis - You cannot maintain a face-down position after surgery Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 t

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.


Locations(1)

Hong Kong

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ACTRN12616001342404