Full Thickness Macular Hole; Should it be Handled Subacutely?

NCT05828251 | Recruiting DMC

• 1 other identifier: Rigshospitalet-RS studie
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

1. 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:
2. 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.

Conditions

Full Thickness Macular Hole

Keywords

Phako; Vitrectomy; Phako-vitrectomy; FTMH

Outcome Measures

Primary Outcomes (1)

• Visual acuity

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

  12 months after vitrectomy

Secondary Outcomes (4)

• Metamorphopsia

  12 months after vitrectomy

• Hole closure rates

  Measured 4 weeks after surgery

• Microperimetry

  12 months after surgery

• Anterior chamber inflammation

  1 day and 1 week after the first surgery

Study Arms (3)

Combined Phako-Vitrectomy for FTMH

EXPERIMENTAL

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

Procedure: Combined phako-vitrectomy

Sequential phako and vitrectomy for FTMH

ACTIVE COMPARATOR

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); Procedure: Phako (Sequential phakoemulsification and vitrectomy)

Longstanding FTMH

OTHER

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); Procedure: Phako (Sequential phakoemulsification and vitrectomy)

Interventions

Vitrectomy (Sequential phakoemulsification and vitrectomy) PROCEDURE

Standard treatment for FTMH at our department with phakoemulsification followed by pars plana vitrectomy and gas 4 weeks later.

Longstanding FTMH; Sequential phako and vitrectomy for FTMH

Combined phako-vitrectomy PROCEDURE

Phakoemulsication and pars plana vitrectomy are performed in the same setting. This procedure is normally only offeres to selected cases at our department.

Combined Phako-Vitrectomy for FTMH

Phako (Sequential phakoemulsification and vitrectomy) PROCEDURE

Standard treatment for FTMH at our department with phakoemulsification followed by pars plana vitrectomy and gas 4 weeks later.

Longstanding FTMH; Sequential phako and vitrectomy for FTMH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet, Denmark

Glostrup Municipality, Copenhagen, 2600, Denmark

RECRUITING

MeSH Terms

Interventions

Vitrectomy

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Morten Dornonville de la Cour, MD, Prof.

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Asrin Rasul, MD

CONTACT

004522365420; asrin.rasul@regionh.dk

Ulrik Christensen

CONTACT

004540261670; ulrik.correll.christensen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: 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.

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 25, 2023
• Study Start: April 30, 2023
• Primary Completion: April 1, 2025
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)