Immediate vs. Deferred Surgery for Macular Pucker

(Protocol AM Trial)

Recruiting at 43 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jaeb Center for Health Research

Disqualifiers: Retinal vascular disease, Vitreous hemorrhage, Inflammatory disease, Diabetic macular edema, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Varies based on immediate or deferred surgery

400 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies the best time for eye surgery to remove a membrane that can cause vision problems. It focuses on patients with noticeable eye changes but still good vision. The goal is to see if surgery leads to better vision outcomes and to understand how symptoms like visual distortion affect patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the treatment for macular pucker?

Research shows that vitrectomy with membrane peeling can improve vision in patients with macular pucker, as seen in studies where most patients experienced visual improvement after surgery. However, there are risks such as retinal tears and cataracts, and not all patients are satisfied with the results. ^{1 2 3 4 5}

Is vitrectomy surgery for macular pucker generally safe?

Vitrectomy surgery, which involves removing the gel-like substance in the eye and peeling the membrane, is generally considered safe for treating macular pucker. Studies comparing different techniques (20-gauge and 25-gauge) have focused on both safety and effectiveness, indicating that the procedure is commonly performed with a good safety profile. ^{1 2 3 6 7}

How does the treatment for macular pucker differ from other treatments?

The treatment for macular pucker using vitrectomy with membrane peeling is unique because it involves surgically removing the epiretinal tissue to improve vision, which is different from non-surgical approaches like watchful waiting. This method can lead to significant visual improvement, although it carries risks such as cataract formation and retinal detachment. ^{2 4 5 8 9}

Eligibility Criteria

This trial is for people with a condition called Macular Pucker, who have vision between 20/25 and 20/40. They should experience visual loss or distortion due to an epiretinal membrane (ERM) affecting the central part of the retina. Surgery shouldn't be urgently needed, and they mustn't have other health issues that make surgery risky.

Inclusion Criteria

Distortion within the central subfield due to ERM on OCT

My eye condition is not caused by another health issue.

I have a membrane affecting the central part of my retina.

Exclusion Criteria

I have had diabetic eye disease, blocked blood vessels in my eye, or eye inflammation.

I have had eye surgery before, but only for cataracts and without complications.

I had an inflammatory disease that was mild and resolved over a year ago.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either immediate or deferred vitrectomy to remove an epiretinal membrane (ERM)

Varies based on immediate or deferred surgery

Follow-up

Participants are monitored for changes in visual acuity and other outcomes

36 months

Treatment Details

Interventions

• Deferred Vitrectomy
• Immediate Vitrectomy

Trial Overview The study compares immediate vs. deferred vitrectomy surgery in patients with symptomatic ERM to determine which timing results in better vision outcomes. It also aims to identify factors predicting success when surgery is performed and progression if it's delayed.

Participant Groups

Group I: Deferred Vitrectomy Experimental Treatment 1 Intervention

Group II: Immediate Vitrectomy Active Control 1 Intervention

Deferred Vitrectomy is already approved in United States, European Union for the following indications:

Approved in United States as Vitrectomy for:

• Epiretinal membrane removal
• Macular pucker treatment
• Retinal disorders

Approved in European Union as Vitrectomy for:

• Epiretinal membrane removal
• Macular pucker treatment
• Retinal disorders

Who Is Running the Clinical Trial?

Jaeb Center for Health Research

Lead Sponsor

Trials

162

Recruited

36,200+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

Juvenile Diabetes Research Foundation

Collaborator

Trials

237

Recruited

142,000+

Findings from Research

In a study of five patients with rapidly progressive macular pucker, early surgical intervention (vitrectomy and epiretinal membrane removal) led to a quick recovery of visual acuity and resolution of visual distortions within 6 weeks to 3 months.

Histopathological analysis indicated that the epiretinal membranes in these cases contained more retinal pigment epithelium-derived cells and formed distinct structures, suggesting that acute macular pucker is a unique condition related to retinal tears or detachments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute macular pucker. Sheard, RM., Sethi, C., Gregor, Z.[2022]

In a study of 67 patients with macular pucker, 37 were monitored conservatively, allowing researchers to observe the natural progression of the disease without intervention.

Among the 30 patients who underwent pars plana vitrectomy with membrane peeling, the study discusses the surgical indications and outcomes, highlighting the effectiveness of this surgical approach for treating macular pucker.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of macular pucker. Christiaens, I., de Lepeleire, K., Leys, A., et al.[2004]

In a study of 107 patients undergoing macular pucker surgery, 83% experienced improved vision and reduced metamorphopsia after one year, with an average vision improvement of 2 ETDRS lines.

At the 5-year follow-up, 70% of the 57 patients who responded to a questionnaire indicated they would choose to have the surgery again, although a significant portion expressed dissatisfaction, suggesting that long-term subjective outcomes may not be as positive as the initial objective improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of macular pucker surgery: 1- and 5-year follow-up. Bouwens, MD., de Jong, F., Mulder, P., et al.[2021]

In a study involving 11 eyes with macular pucker after retinal reattachment surgery, vitrectomy techniques successfully improved vision in all cases, demonstrating the efficacy of this intervention.

Despite some risks, including one retinal tear and two cases of recurrent detachment, the procedure can lead to significant visual improvement, with the best postoperative acuity reaching 20/40.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vitrectomy techniques in treatment of macular pucker following retinal reattachment surgery. Michels, RG., Gilbert, HD.[2004]

In a study involving 6 patients with macular puckers, surgical removal of the epiretinal tissue through vitrectomy and membrane peeling led to initial visual improvement in 5 patients, with 3 experiencing permanent improvement.

While complications such as cataract and retinal detachment were noted, there was no recurrence of the macular pucker, indicating the procedure's effectiveness in addressing the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The surgical removal of epiretinal macular membranes (macular puckers) (author's transl)]. Machemer, R.[2022]

Macular pucker occurred in 7.7% of patients after successful retinal detachment surgery, with final visual acuity of 0.5 or better achieved in 24 cases, indicating that while some patients improved, others experienced significant visual impairment.

Nine risk factors were identified that increase the likelihood of developing macular pucker, including preoperative visual acuity and the presence of retinal tears, suggesting that careful monitoring of these factors could help manage patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Macular fibrosis after surgery of retinal detachment]. Girard, P., Karpouzas, I., Saade, G.[2006]

In a study of 67 patients with macular pucker, 25-gauge vitrectomy showed a significantly faster improvement in best-corrected visual acuity (BCVA) at one month compared to 20-gauge vitrectomy, indicating its potential for quicker recovery.

Both techniques resulted in similar visual outcomes by six months, suggesting that while 25-gauge vitrectomy may offer initial advantages, long-term results are comparable between the two methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of visual function after epiretinal membrane removal by 20-gauge and 25-gauge vitrectomy. Kadonosono, K., Yamakawa, T., Uchio, E., et al.[2022]

A case was reported where a macular pucker, which usually requires surgical treatment, spontaneously peeled off after cryotherapy for peripheral retinal tumors, suggesting a potential non-surgical resolution.

This case highlights the possibility of spontaneous recovery in certain conditions affecting the macula, which could influence treatment approaches for similar cases in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Spontaneous peeling of the epimacular membrane after cryotherapy of retinal vasoproliferative tumors: report of a case]. Coulier, J., Gribomont, AC., De Potter, P.[2014]

In a study of 26 eyes with post-uveitic macular pucker, patients showed significant improvement in visual acuity after vitrectomy, with average vision increasing from 20/80 to 20/40, and 77% of eyes experiencing improved vision.

The surgery also led to a reduction in central foveal thickness, indicating a positive change in retinal health, suggesting that vitrectomy can be beneficial for patients with uveitic epiretinal membranes when performed after inflammation has resolved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical management of post-uveitic epiretinal membranes. Coassin, M., Mori, T., Mastrofilippo, V., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Acute macular pucker. [2022]

2. Belgium pubmed.ncbi.nlm.nih.gov

Management of macular pucker. [2004]

3. Germany pubmed.ncbi.nlm.nih.gov

Results of macular pucker surgery: 1- and 5-year follow-up. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Vitrectomy techniques in treatment of macular pucker following retinal reattachment surgery. [2004]

5. Germany pubmed.ncbi.nlm.nih.gov

[The surgical removal of epiretinal macular membranes (macular puckers) (author's transl)]. [2022]

6. France pubmed.ncbi.nlm.nih.gov

[Macular fibrosis after surgery of retinal detachment]. [2006]

7. United States pubmed.ncbi.nlm.nih.gov

Comparison of visual function after epiretinal membrane removal by 20-gauge and 25-gauge vitrectomy. [2022]

8. Belgium pubmed.ncbi.nlm.nih.gov

[Spontaneous peeling of the epimacular membrane after cryotherapy of retinal vasoproliferative tumors: report of a case]. [2014]

9. United States pubmed.ncbi.nlm.nih.gov

Surgical management of post-uveitic epiretinal membranes. [2022]