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Full Thickness Macular Hole; Should it be Handled Subacutely?

Primary Purpose

Full Thickness Macular Hole

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Vitrectomy (Sequential phakoemulsification and vitrectomy)
Combined phako-vitrectomy
Phako (Sequential phakoemulsification and vitrectomy)
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Full Thickness Macular Hole focused on measuring Phako, Vitrectomy, Phako-vitrectomy, FTMH

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Idiopathic full thickness macular hole Duration of symptoms of <30 days for Group 1 and 2 Duration of symptoms of 3-12 months for Group 3 FTMH size <400µm >18 years Able to give informed consent Compliance for postoperative positioning Exclusion Criteria: High myopia (≤-3) Traumatic macular hole Prior ocular surgery, including cataract surgery Other ocular diseases compromising the visual acuity (i.e., AMD, diabetic retinopathy, previous vein occlusion) Posterior vitreous detachment (Weiss ring)

Sites / Locations

  • Rigshospitalet, DenmarkRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Combined Phako-Vitrectomy for FTMH

Sequential phako and vitrectomy for FTMH

Longstanding FTMH

Arm Description

Study 1: Patient randomized to this arm will receive a combined phako-vitrectomy within two weeks from referall day.

Study 1: Patients randomized to this arm will receive a standard phacoemulsification as soon as possible. About four weeks after phacoemulsification a vitrectomy is performed.

Study 2: Patients with symptomduration of 3-12 months will be included in this part of the study in a prospective design.

Outcomes

Primary Outcome Measures

Visual acuity
Best corrected visual acuity measured with ETDRS, the ETDRS scoe will be converted to LogMAR

Secondary Outcome Measures

Metamorphopsia
Measured by M-charts, for vertical and horisontal metamorfopisa. The M-charts consist of 19 dotted (dot size is 0.1°) lines with dot intervals ranging from 0.2° to 2.0° of visual angle.
Hole closure rates
Either the hole closes og it doesn't.
Microperimetry
Microperimetry is a procedure to assess retinal sensitivity while fundus is directly examined; it enables exact correlation between macular pathology and corresponding functional abnormality. Measured in mean retinal sensitivity (dB)
Anterior chamber inflammation
(FM). The FM is based on the measurement principle of laser light scattering detection. The instrument uses a diode laser beam to scan a measuring window that is projected inside the anterior chamber of the eye. As an aqueous protein (component of inflammation) passes through the focal point of the laser,light scattering occurs. The intensity of the scattered light (directly proportional to the amount of protein particles-flare) is detected by a photo-multiplier tube (PMT), which generates an electrical signal. This signal is immediately digitized to eliminate outside noise interference and are processed by a computer which displays the results for user analysis. The unit of measurement employed by the FM is "Photon Count" per millisecond.

Full Information

First Posted
March 22, 2023
Last Updated
April 22, 2023
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT05828251
Brief Title
Full Thickness Macular Hole; Should it be Handled Subacutely?
Official Title
Full Thickness Macular Hole; Should it be Handled Subacutely?
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 30, 2023 (Anticipated)
Primary Completion Date
April 1, 2025 (Anticipated)
Study Completion Date
April 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Full thickness macular hole, FTMH, is a retinal disease involving the fovea that cause central vision loss, metamorphopsia and central scotoma. The most effective treatment for FTMH is a pars plana vitrectomy and a tamponade with expansile gas. It is well known that vitrectomy accelerates cataract development. Vitrectomy can therefore be combined with cataract surgery in the same setting, a procedure that is shown to be safe, although increased inflammation and rates of central macular edema have been reported in some studies. Cataract surgery can also be performed prior or deferred until compromising the visual acuity after vitrectomy. Cataract-surgeries are more challenging in vitrectomized eyes due to lack of vitreous support and risk of loose zonules. The normal practice for FTMH at our department is therefore cataract surgery followed by vitrectomy 4 weeks later. A combined phaco-vitrectomy procedure is offered to patients who are at the labor market or when general anesthesia is required for the surgery. In non-presbyopic patients (<50 years) only vitrectomy is performed. The visual improvement after surgery seems to be dependent on preoperative characteristics, such as the preoperative visual acuity, size of the hole and the duration of symptoms. The duration of symptoms is a known prognostic factor, and recently shown that the longer duration, the worse visual outcome. The precise timeframe for the optimal final outcome is not known. The combined surgery is known to be safe in the treatment for epiretinal membrane, where a intravitreal gasfill is not necessary. However, the use of gas in FTHM surgery causes risk of increased movement of the newly inserted intraocular lens. This can lead to increased anterior segment inflammation with ensuing vision threatening cystic macular edema, as mentioned above. The purpose of this study is to investigate whether small FTMH with a short duration of symptoms have better visual outcome with a prompt combined phako-vitrectomy (within two weeks), compared to the current standard of care of receiving cataract surgery as soon as possible and vitrectomy 4 weeks later. How the delay of surgery affects the visual outcome will also be investigated, by including patients with longer duration of symptoms. The main hypothesis is that the chance of better visual outcome is higher for macular holes with early surgery compared to the current standard of care and that the duration of symptoms has significant impact on the visual outcome. Method The study consists of 2 parts. Patients with idiopathic FTMH <400µm in diameter (as defined by The international vitreomacular traction study group classification), with a duration of symptoms of less than 30 days will be randomized into 2 groups: Group1: Combined phaco-vitrectomy within 2 weeks (after referral). Group 2: Current standard of care with cataract surgery as soon as possible and vitrectomy 4 weeks later. Group 3: Patients with small holes <400µm, with a duration of symptoms of more than 3 months and less than one year will be included in this part of the study. These patients will be treated and followed as in Group 2. They will be reviewed a total of 7 times in Group 1 and 9 times in Group 2 and 3: a preoperative examination followed by 6/8 postoperative examinations. Additional examinations will be scheduled if needed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Full Thickness Macular Hole
Keywords
Phako, Vitrectomy, Phako-vitrectomy, FTMH

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial in the first part om of the study, 28 patients in each arm. Prospective study in second part of the study with 28 patients.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combined Phako-Vitrectomy for FTMH
Arm Type
Experimental
Arm Description
Study 1: Patient randomized to this arm will receive a combined phako-vitrectomy within two weeks from referall day.
Arm Title
Sequential phako and vitrectomy for FTMH
Arm Type
Active Comparator
Arm Description
Study 1: Patients randomized to this arm will receive a standard phacoemulsification as soon as possible. About four weeks after phacoemulsification a vitrectomy is performed.
Arm Title
Longstanding FTMH
Arm Type
Other
Arm Description
Study 2: Patients with symptomduration of 3-12 months will be included in this part of the study in a prospective design.
Intervention Type
Procedure
Intervention Name(s)
Vitrectomy (Sequential phakoemulsification and vitrectomy)
Intervention Description
Standard treatment for FTMH at our department with phakoemulsification followed by pars plana vitrectomy and gas 4 weeks later.
Intervention Type
Procedure
Intervention Name(s)
Combined phako-vitrectomy
Intervention Description
Phakoemulsication and pars plana vitrectomy are performed in the same setting. This procedure is normally only offeres to selected cases at our department.
Intervention Type
Procedure
Intervention Name(s)
Phako (Sequential phakoemulsification and vitrectomy)
Intervention Description
Standard treatment for FTMH at our department with phakoemulsification followed by pars plana vitrectomy and gas 4 weeks later.
Primary Outcome Measure Information:
Title
Visual acuity
Description
Best corrected visual acuity measured with ETDRS, the ETDRS scoe will be converted to LogMAR
Time Frame
12 months after vitrectomy
Secondary Outcome Measure Information:
Title
Metamorphopsia
Description
Measured by M-charts, for vertical and horisontal metamorfopisa. The M-charts consist of 19 dotted (dot size is 0.1°) lines with dot intervals ranging from 0.2° to 2.0° of visual angle.
Time Frame
12 months after vitrectomy
Title
Hole closure rates
Description
Either the hole closes og it doesn't.
Time Frame
Measured 4 weeks after surgery
Title
Microperimetry
Description
Microperimetry is a procedure to assess retinal sensitivity while fundus is directly examined; it enables exact correlation between macular pathology and corresponding functional abnormality. Measured in mean retinal sensitivity (dB)
Time Frame
12 months after surgery
Title
Anterior chamber inflammation
Description
(FM). The FM is based on the measurement principle of laser light scattering detection. The instrument uses a diode laser beam to scan a measuring window that is projected inside the anterior chamber of the eye. As an aqueous protein (component of inflammation) passes through the focal point of the laser,light scattering occurs. The intensity of the scattered light (directly proportional to the amount of protein particles-flare) is detected by a photo-multiplier tube (PMT), which generates an electrical signal. This signal is immediately digitized to eliminate outside noise interference and are processed by a computer which displays the results for user analysis. The unit of measurement employed by the FM is "Photon Count" per millisecond.
Time Frame
1 day and 1 week after the first surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Idiopathic full thickness macular hole Duration of symptoms of <30 days for Group 1 and 2 Duration of symptoms of 3-12 months for Group 3 FTMH size <400µm >18 years Able to give informed consent Compliance for postoperative positioning Exclusion Criteria: High myopia (≤-3) Traumatic macular hole Prior ocular surgery, including cataract surgery Other ocular diseases compromising the visual acuity (i.e., AMD, diabetic retinopathy, previous vein occlusion) Posterior vitreous detachment (Weiss ring)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Asrin Rasul, MD
Phone
004522365420
Email
asrin.rasul@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Ulrik Christensen
Phone
004540261670
Email
ulrik.correll.christensen@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morten Dornonville de la Cour, MD, Prof.
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet, Denmark
City
Glostrup
State/Province
Copenhagen
ZIP/Postal Code
2600
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Morten Dornonville de la Cour, MD, Prof.

12. IPD Sharing Statement

Plan to Share IPD
No

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Full Thickness Macular Hole; Should it be Handled Subacutely?

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