Full Thickness Macular Hole; Should it be Handled Subacutely?

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.

1. 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.

2. 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.

Study Overview

• Status: Recruiting
• Conditions: Full Thickness Macular Hole
• Intervention / Treatment: Procedure: Combined phako-vitrectomy; Procedure: Vitrectomy (Sequential phakoemulsification and vitrectomy); Procedure: Phako (Sequential phakoemulsification and vitrectomy)

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Asrin Rasul, MD; Phone Number: 004522365420; Email: asrin.rasul@regionh.dk
• Study Contact Backup: Name: Ulrik Christensen; Phone Number: 004540261670; Email: ulrik.correll.christensen@regionh.dk

Study Locations

• Denmark
  • Copenhagen
    • Glostrup, Copenhagen, Denmark, 2600
      • Recruiting
      • Rigshospitalet, Denmark
      • Contact: Morten Dornonville de la Cour, MD, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combined Phako-Vitrectomy for FTMH; Study 1: Patient randomized to this arm will receive a combined phako-vitrectomy within two weeks from referall day.	Procedure: Combined phako-vitrectomy; Phakoemulsication and pars plana vitrectomy are performed in the same setting. This procedure is normally only offeres to selected cases at our department.
Active Comparator: Sequential phako and vitrectomy for FTMH; 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.	Procedure: Vitrectomy (Sequential phakoemulsification and vitrectomy); Standard treatment for FTMH at our department with phakoemulsification followed by pars plana vitrectomy and gas 4 weeks later.; Procedure: Phako (Sequential phakoemulsification and vitrectomy); Standard treatment for FTMH at our department with phakoemulsification followed by pars plana vitrectomy and gas 4 weeks later.
Other: Longstanding FTMH; Study 2: Patients with symptomduration of 3-12 months will be included in this part of the study in a prospective design.	Procedure: Vitrectomy (Sequential phakoemulsification and vitrectomy); Standard treatment for FTMH at our department with phakoemulsification followed by pars plana vitrectomy and gas 4 weeks later.; Procedure: Phako (Sequential phakoemulsification and vitrectomy); Standard treatment for FTMH at our department with phakoemulsification followed by pars plana vitrectomy and gas 4 weeks later.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity	Best corrected visual acuity measured with ETDRS, the ETDRS scoe will be converted to LogMAR	12 months after vitrectomy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months after vitrectomy
Hole closure rates	Either the hole closes og it doesn't.	Measured 4 weeks after surgery
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)	12 months after surgery
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.	1 day and 1 week after the first surgery

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Morten Dornonville de la Cour, MD, Prof., Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2023
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: March 22, 2023
• First Submitted That Met QC Criteria: April 22, 2023
• First Posted (Actual): April 25, 2023

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Vitrectomy; FTMH; Phako; Phako-vitrectomy
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Perforations
• Other Study ID Numbers: Rigshospitalet-RS studie

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No