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Surgical Outcome of Macular Membrane Peeling Associated With Significant Macular Drusen

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ClinicalTrials.gov Identifier: NCT03927430
Recruitment Status : Completed
First Posted : April 25, 2019
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Katrin Engelmann, Klinikum Chemnitz gGmbH

Tracking Information
First Submitted Date April 15, 2019
First Posted Date April 25, 2019
Last Update Posted Date May 1, 2019
Actual Study Start Date January 1, 2019
Actual Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 24, 2019)
number of patients with CNV [ Time Frame: last visit, in common 6 months postoperatively ]
number of patients with CNV (choroidal neovascularization) development
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03927430 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 24, 2019)
  • BCVA [ Time Frame: last visit, in common 6 months postoperatively ]
    best corrected visual acuity
  • incidence of central retinal atrophy [ Time Frame: last visit, in common 6 months postoperatively ]
    development of central retinal atrophy on OCT
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Surgical Outcome of Macular Membrane Peeling Associated With Significant Macular Drusen
Official Title To Peel or Not to Peel: Surgical Outcome of Macular Membrane Peeling Associated With Significant Macular Drusen
Brief Summary Surgical outcome of patients with macular drusen and co-existing abnormalities of the vitreoretinal interface, who routinely undergo pars plana vitrectomy with membrane peeling, is evaluated. Best corrected visual acuity as well as optical coherence tomography data are compared at baseline and last follow up. The rate of development of choroidal neovascularization postoperatively is noted.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population mostly elderly people, mean age 66 years, both males and females
Condition
  • Epiretinal Membrane
  • Macular Holes
  • Age Related Macular Degeneration
Intervention Procedure: pars plana vitrectomy with membrane peeling
23-gauge pars plana vitrectomy with peeling of the epiretinal and internal limiting membrane as well as air- or gastamponade
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 24, 2019)
40
Original Actual Enrollment Same as current
Actual Study Completion Date March 1, 2019
Actual Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. participants diagnosed with ERM or FTMH and co-existing macular drusen;
  2. undergone pars plana vitrectomy with ILM and epiretinale membrane peeling;
  3. SD-OCT at the initial visit and at last follow up visit with image quality score >30;
  4. no evidence of CNV on initial fluorescein angiography (FA).

Exclusion Criteria:

  1. history of other macular disease, severe non-proliferative or proliferative diabetic retinopathy, other retinal vascular diseases, glaucoma, myopic retinopathy, or other diseases interfering with OCT images in any one of the eyes;
  2. active CNV or history of CNV
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT03927430
Other Study ID Numbers SKC01/2019
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Katrin Engelmann, Klinikum Chemnitz gGmbH
Study Sponsor Klinikum Chemnitz gGmbH
Collaborators Not Provided
Investigators
Study Chair: Katrin Engelmann, PhD Klinikum Chemnitz
PRS Account Klinikum Chemnitz gGmbH
Verification Date April 2019