Preoperative Progression of Macular Holes

NCT ID: NCT02203929

Last Updated: 2016-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-03-31

Brief Summary

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Knowledge of the natural history and progression of macular holes is mainly limited to the studies from the pre-optical coherence tomography era. By observing macular holes preoperatively we are able to determine the extent of the preoperative macular hole progression.

At our institution macular holes are treated in an elective setting. The majority of macular holes undergo a 2-step sequence of phacoemulsification and intraocular lens implantation followed by vitrectomy.

We wish to observe the effect of time and cataract surgery on the progression of macular holes prior to vitrectomy.

Detailed Description

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Conditions

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Macular Holes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Phakic eyes

Phakic eyes will be monitored with 4 preoperative optical coherence tomography scans as these patients will undergo phacoemulsification and intraocular lens implantation prior to their macular hole surgery

No interventions assigned to this group

Pseudophakic eyes

Phakic eyes will be monitored with 2 preoperative optical coherence tomography scans as there is no surgical intervention prior to the macular hole treatment.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Idiopathic macular hole stage II-IV
* Informed consent
* Duration of symptoms ≤ 24 months

Exclusion Criteria

* Previous vitreomacular surgery
* Ocular trauma
* Significant visual function affecting disease (proliferative diabetic retinopathy, diabetic macular edema, exudative macular degeneration)
Minimum Eligible Age

40 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Mark Alberti

BSc.med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Morten la Cour, DMSc

Role: STUDY_DIRECTOR

Glostrup University Hospital, Copenhagen

Locations

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Glostrup Hospital, University of Copenhagen

Glostrup Municipality, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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MH-Progression

Identifier Type: -

Identifier Source: org_study_id

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