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Trial record 27 of 34 for:    myopic macular degeneration

Pars Plana Vitrectomy Alone in the Treatment of Macular Schisis in High Myopic Eyes

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ClinicalTrials.gov Identifier: NCT03586193
Recruitment Status : Recruiting
First Posted : July 13, 2018
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Aier School of Ophthalmology, Central South University

Brief Summary:
High myopic schisis (HMF) has the clinical feature of separation between retinal layers. It is sometimes accompanied with foveal retinal detachment, macular lamellar hole, epiretinal membrane and vitreous retraction. HMF may develop to macular hole, macular detachment and will damage the visual function. Pars plana vitrectomy (PPV) is a commonly used surgery in the treatment of HMF. PPV together with internal limiting membrane (ILM) peeling and long-term gas tamponade was reported to be safe and effective. But nowadays there was no available long-term gas in our country. Also, whether ILM peeling is necessary remains controversial, Indole cyanine green (ICG)was proved to have potential toxicity to the retina and the ILM peeling has the risk of causing secondary macular hole. We propose to make a prospective nonrandomized controlled study to evaluate the safety and efficiency of using PPV alone in the treatment of HMF.

Condition or disease Intervention/treatment
Retinal Disease Macular Retinoschisis Procedure: Pars plana vitrectomy

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Application of Pars Plana Vitrectomy in the Treatment of Macular Schisis in High Myopic Eyes
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
patients with HMF
Patients who are diagnosed as high myopic macular schisis and agree to receive pars plana vitrectomy as the treatment are planned to allocated in this group
Procedure: Pars plana vitrectomy
pars plana vitrectomy without ICG staining and ILM peeling




Primary Outcome Measures :
  1. The morphologic change of macular area [ Time Frame: OCT will be done one day before surgery and one week, one month, three months and six months after surgery ]
    The thickness of the macular fovea in optical coherence tomography (OCT)


Secondary Outcome Measures :
  1. The best corrected visual acuity (BCVA) change [ Time Frame: One day before surgery and one week, one month, three months and six months after surgery ]
    The BCVA of all involved patients

  2. The best corrected near visual acuity (BCNVA) change [ Time Frame: One day before surgery and one week, one month, three months and six months after surgery ]
    The BCNVA of all involved patients

  3. The visual function change [ Time Frame: One day before surgery and one week, one month, three months and six months after surgery ]
    The contrast sensitivity of all involved patients



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study population will be selected from the in-patients in Shanghai Aier Eye Hospital.
Criteria

Inclusion Criteria:

  1. Patients diagnosed as high myopic macular retinoschisis, with axial length more than 26.5mm.
  2. Morphologic manifestation in OCT shows split between retinal layers in macular area.
  3. Patients without severe systemic disease and can tolerate surgery.

Exclusion Criteria:

  1. Patients also have other ocular disease, including glaucoma, keratitis,uveitis, retinal detachment,etc.
  2. Patients with nystagmus or have difficult to open the eye.
  3. Patients with severe systemic disease and cannot tolerate surgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03586193


Contacts
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Contact: Zhuyun Qian, Doctor +8613817109809 ext +8618650424985 qianzhuyun552@126.com
Contact: Wensheng Li, Doctor +8618650424985 ext +8618650424985 drlws@qq.com

Locations
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China
Shanghai Aier Eye hospital Recruiting
Shanghai, China, 200000
Contact: Zhuyun Qian, Doctor    +8613817109809 ext +8618650424985    qianzhuyun552@126.com   
Contact: Wensheng Li, Doctor    +8618650424985 ext +8618650424985    drlws@qq.com   
Sponsors and Collaborators
Aier School of Ophthalmology, Central South University
Investigators
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Study Director: Wensheng Li, Doctor Shanghai Aier Eye Hospital

Publications of Results:
Other Publications:
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Responsible Party: Aier School of Ophthalmology, Central South University
ClinicalTrials.gov Identifier: NCT03586193     History of Changes
Other Study ID Numbers: SHIRB2018014
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all individual participant data (IPD) that underlie results
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: After this study is finished the data will become available for 1year.
Access Criteria: The analytical data will be accessed in published articles.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Retinal Degeneration
Retinal Diseases
Retinoschisis
Eye Diseases
Temazepam
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action