Cochrane Review of Randomized Controlled Trials of the Treatment of Imhs With Vitrectomy

Introduction

A macular hole (MH) is a defined as a full-thickness defect of the neuroretina in the macular foveal surface area. Traumatic macular holes (TMH) represent approximately ten% of MHs and may event in permanent meaning vision loss (i). TMH is oftentimes found in young men, as the condition it is frequently associated with sport- and work-related accidents (2). The functional outcomes are often unclear because of the accompanying trauma-induced retinal pathologies, such as vitreous hemorrhage, retinal detachment, retinal hemorrhage, choroidal fracture, subretinal choroidal neovascularization, and fibrosis.

However, the posttraumatic approach is controversial. To date, no clinical guidelines accept been established for this vision-threatening illness. Handling includes vitrectomy surgery and ascertainment, also as spontaneous closure (1). Vitrectomy has been reported to meliorate anatomical and visual outcomes in eyes with TMH (3, four). Currently, surgical techniques include removing the posterior vitreous cortex and epiretinal membranes, with or without internal limiting membrane (ILM) peeling, and intraocular gas or silicone oil tamponade. Various adjuvant therapies, including transforming growth factor-beta (TGF-β), biological tissue adhesives, and platelet concentrate, have been investigated with varying degrees of success (5, six). Even so, in that location are many unanswered questions most the necessity of surgery considering spontaneous hole closure has been normally reported (vii). Many studies have reported that spontaneous closure usually occurs between 1 and 6 months afterwards the trauma incident (viii, 9). While a number of studies have discussed the anatomical and visual outcomes of surgery and ascertainment on TMH, a previous systemic review and meta-analysis, which included only 10 studies, lacked sufficient item (10). Therefore, in this systematic review and meta-analysis, we systematically and statistically determined the comeback rates with TMH closure and visual acuity (VA) past comparison the two methods of treating TMH.

Materials and Methods

This systematic review and meta-analysis was performed according to the Meta-analyses Of Observational Studies in Epidemiology (MOOSE) guidelines (xi). Ethical approval was not necessary for the study as information technology used published data. Iv databases in English, including PubMed, Cochrane, Web of Scientific discipline Library, and Embase, and four databases in Chinese, including CNKI, Wanfang, VIP, and Sino Med, were searched from their inception to June ten, 2021. Google Scholar and Baidu Scholar were also searched to find studies missing in those databases. A transmission search was conducted to identify published studies. In the case of unpublished studies, the database was searched for their abstracts, and their authors were as well contacted. EndNote was used to merge retrieved citations and eliminate duplications.

Two independent researchers (QZ and HYF) separately assessed the eligibility, extracted the data, and assessed the quality of the included studies, and a tertiary writer (HJY) determined the final criteria for any inconsistencies.

Search Strategy

The search strategy included the following search terms: "retinal perforations," "retinal hole," "retinal tear," "retinal break," "macular hole," "traumatic macular hole," "vitrectomy," "pars plana vitrectomy," "surgical management," "ascertainment," "handling," and "spontaneous closure." The search terms are shown in the Supplementary Material.

Inclusion Criteria

Articles were included if they (1) included studies on patients with TMH; (ii) used closure rate and VA improvement rate as the treatment endpoints; (iii) provided clinical statistics on age, sex, best-corrected visual acuity (BCVA) expressed in the logarithm of the minimal angle of resolution (logMAR), MH size, follow-up information, operation, interval from injury to surgery, TMH closure rate, and VA improvement rate; and (4) were published in Chinese or English full text.

Exclusion Criteria

Articles were excluded if they (1) reported duplicated or overlapping data; (2) were designed as "reviews," "case reports," "messages" or "conference manufactures" with no data to extract; (iii) focused on patients diagnosed with idiopathic MH, myopic MH, or TMH with retinal detachment; and (4) were not published in Chinese or English full text.

Data Extraction

Co-ordinate to the inclusion and exclusion criteria, two researchers (QZ and HYF) independently read the full text of the manufactures and selected the qualified studies. The following information was extracted from eligible studies: showtime author and publication twelvemonth, study design, country, follow-up time, sexual practice, number of participants, BCVA logMAR before and subsequently TMH closure, size of TMH (μm), closure rate, and VA comeback rate. For the surgery group patients, information on the interval from the injury to the surgery were extracted. For the observation group patients, data on the time of hole closure were extracted.

Quality Assessment

To accurately evaluate the methodological quality of eligible studies, two researchers independently used the Newcastle-Ottawa Scale, which is a nine-betoken system including participant selection (0–iv points), comparability (0–two points), and exposure (0–3 points) (12). Scores of 0–3, 4–half dozen, and 7–ix points were regarded as low, moderate, and high quality, respectively. All included studies were identified to be of moderate or high methodological quality (Supplementary Material).

Statistical Assay

The principal outcomes were TMH closure charge per unit and VA improvement rate in both groups. BCVA comeback in the surgery group was defined as a secondary outcome.

Continuous data are presented as mean ± standard deviation. The descriptive statistics (BCVA logMAR comeback, TMH closure, and VA improvement rate) were analyzed with a 95% conviction interval (CI). The Cochran Q exam and I ² statistic were used to identify heterogeneity among the studies. When there was no meaning heterogeneity (I ² < 50% or P > 0.05), we practical a stock-still-effect model to guess the pooled outcome size; otherwise, a random-effect model was employed. Funnel plots were used to detect potential publication bias. A sensitivity analysis was performed to test the robustness of the analysis. A subgroup analysis was conducted to explore the potential heterogeneity amidst patients in the surgery according to the different surgical procedures. All data synthesis and analysis were performed using Stata version 15.1.

Results

Literature Search and Study Selection

A full of 574 records were identified with the initial search strategy. Subsequently removing 336 duplicates, 238 studies were assessed by championship and abstract. Thirty-6 studies, including 33 retrospective studies and three prospective studies, were selected for our meta-analysis according to the inclusion and exclusion criteria. The details of the search strategy are shown in Figure ane.

Figure i. Catamenia nautical chart of the study selection (through June 10, 2021).

Characteristics of the Study Samples

Xxx-two studies, as shown in Table 1, reported information on patients (n = 734) who underwent vitrectomy. For the surgery group patients, vitrectomies were performed using adjunctive therapies, including ILM peeling or flap, platelet concentrate or TGF-β, and gas or silicon oil tamponade. Most of the patients were males, with a similar proportion in both groups. The mean age of the surgery group patients was 26.95 years (n = 671; range, 1–69 years). The mean follow-up time was 10.41 ± six.48 months (n = 662; median, 12; range, 3–45 months). The interval from injury to surgery ranged from 1 week to 120 months, and the boilerplate size of the TMH was 628.84 μm (northward = 358; range, 64–one,588 μm). The mean preoperative and postoperative BCVA were 0.87 logMAR (n = 247) and 0.48 logMAR (due north = 247), respectively. The pooled result rate for BCVA comeback in the surgery group was 0.39 (95% CI, 0.33–0.46).

Table 1. Study design and baseline patient characteristics of the surgery group studies.

For the observation group, 12 studies and 275 patients were analyzed (Table two). The average age of the ascertainment group patients was 30.36 years (n = 157; range, 9–49 years), the mean follow-upwardly time was x.56 ± 5.15 months (due north = 275, median, 12; range, 3–48 months), and the average size of the TMH was 561.10 μm (n = 93; range, 553.half dozen–681.4 μm). The percentage of patients who achieved TMH closure in <6 months was > eighty%.

Table ii. Study design and baseline patient characteristics of observation group studies.

Pooled Rates of Closure and VA Improvement for the Surgery Group

In the surgery group, the pooled rates of TMH closure and VA comeback were reported in 31 studies (709 eyes) and 28 studies (651 eyes), respectively. The random-model pooled rate for TMH closure was 0.9 (95% CI, 0.85–0.94, Figure 2A), while that for VA improvement was 0.72 (95% CI, 0.63–0.80). In that location was high heterogeneity between the studies (I ² = 64.19%, P < 0.05; I ² = 81.13%, P < 0.05, Effigy 2B). The Funnel plots did not reveal evidence of publication bias (Supplementary Cloth). For the TMH closure rate, sensitivity analysis suggested that one written report (31) may have been a potential source of heterogeneity (Supplementary Textile). After excluding this report, the pooled charge per unit of TMH closure in the remaining 30 studies was 0.89 (95% CI, 0.85–0.92, I ^two = twoscore.10%, P < 0.05).

Figure ii. Forest plot for TMH closure rate (A) and VA improvement rate (B) of surgery group patients. TMH, traumatic macular hole; VA, visual vigil.

The results of the subgroup analyses are shown in Table iii. In that location was no significant divergence in TMH closure charge per unit between subgroups stratified past unlike types of functioning. Statistically significant furnishings of the subgroups were identified for VA improvement charge per unit and BCVA logMAR improvement (P < 0.05 for heterogeneity between groups).

Table 3. Subgroup analysis for outcomes.

The pooled event charge per unit of TMH closure was higher in the pars plana vitrectomy (PPV) + ILM peeling + perfluoropropane (C3F8)/sulfur hexafluoride (SF6)/hexafluoroethane (C2F6) group (0.88, 95% CI: 0.82–0.93, I ² = 37.22%, Tabular array iii) than in the PPV + ILM peeling + air group (0.75, 95% CI: 0.63–0.86, I ⁱⁱ = 0%, Table three). However, there was still unexplained heterogeneity (I ² > fifty%) between subgroups in the VA comeback charge per unit, which the subgroup assay could not completely explain. For BCVA logMAR improvement, the patients in the PPV+ILM peeling + platelet concentrate + intraocular tamponade grouping had a better BCVA improvement (0.25, 95% CI: 0.xvi–0.35, I ² = 0%, Table 3) than those in the PPV + ILM peeling + intraocular tamponade group (0.45, 95% CI: 0.41–0.48, I ² = 0%, Tabular array iii). Meta-regression revealed that different types of operations affected the results of BCVA logMAR improvement.

Pooled Rates of Closure and VA Improvement for the Observation Group

For the ascertainment group, the rate of TMH closure and VA comeback was reported in 12 studies (275 optics). The random-model pooled charge per unit for TMH closure was 0.37 (95% CI, 0.26–0.48). There was loftier heterogeneity amid the studies (I ² = 71.07%, P < 0.05) (Figure 3A). The included studies were non randomized controlled trials (RCTs), which may be a potential source of heterogeneity. Publication bias was non assessed. Sensitivity analysis showed that the results were robust (Supplementary Material). The pooled event charge per unit for VA comeback was 0.39 (95% CI, 0.33–0.45; stock-still model) with no heterogeneity between the studies (I ⁱⁱ = 0.00%, P > 0.05) (Figure 3B).

Figure three. Wood plot for TMH closure rate (A) and VA improvement rate (B) of observation group patients. TMH, traumatic macular hole; VA, visual acuity.

Adverse Furnishings

Mild vitreous hemorrhage was noted in one patient ane day after vitrectomy surgery, which resolved inside 1 week (40). Vitreoretinal surgery combined with the apply of intraocular gases can issue in elevated postoperative intraocular pressure level (IOP) and cataract formation. Three studies reported increased IOP afterward surgery, only it was controlled within the normal range later on medication (30, 37). In six studies, 24 patients developed cataract formation or dispatch during the follow-up period (17, 23, 29, xxx, 37). After the operation, three patients from 2 studies adult retinal detachment (17, 31). Ane of the reasons for this was an improper surgical operation. None of the patients in these studies developed endophthalmitis. In the observation group, 17 eyes developed obvious hole enlargement and 2 eyes had retinal detachment (43, 44).

Give-and-take

Summary of the Principal Results

We obtained several results by combining the existing evidence. First, although the studies included in our meta-analysis were of moderate or loftier methodological quality, there were no RCTs of TMH handling, which may have led to a lack of convincing results. Second, the rates of TMH closure and VA improvement were significantly college in the surgery group than in the observation grouping. This testify may represent the best available support for treating patients with vitrectomy. Third, TMH patients were younger and mainly males, and over 80% of them showed closure with observation in <6 months. Raised IOP and cataracts are mutual postoperative complications, but these will not be severely agin if firsthand and proper treatment is adopted.

Rate of Closure and VA Improvement Co-ordinate to Vitrectomy Surgery

In this systematic review, the TMH closure charge per unit ranges from 0.63 to 1.0 with a pooled event rate of 0.90, while the VA improvement rate ranges from 0.28 to 1.0, with a pooled effect rate of 0.72 in patients undergoing surgery. Co-ordinate to the study past Wang and Peng (47), the closure and VA improvement rates were 0.83 and 0.84, respectively, so that our results are like to theirs, and showed that vitrectomy surgery seems to be a more effective method than observation for TMH treatment. The widespread utilize of optical coherence tomography (OCT) can offer further insight into the nature of TMH and shed low-cal on the possible reasons for this Miller et al. (2) reported that an intact ellipsoid zone in closed holes tended to correlate with improved final visual acuity. A multicenter prospective comparative study showed that in that location were no significant differences in the length of the photoreceptor IS/Os junction (ellipsoid zone) defect and the final BCVA between the surgically airtight cases and spontaneously closed cases, with fourscore% of the patients showing spontaneous pigsty closure within 3 months (7). Thus a 3-month observation period afterwards injury may exist an alternative modality for TMH management. Therefore, many researchers suggested that vitreous surgery should exist carried out in 3 months to prevent astringent photoreceptor amercement. The closure rate was higher than the VA improvement rate in the surgery grouping, and the differences between anatomical and functional outcomes may exist associated with different preoperative retinal pathologies and ocular complications (one). The study by Qu et al. (31), which reported a TMH closure rate of 1.0, may be a potential source of heterogeneity. The reason for the loftier closure rate may be associated with the use of adjunctive therapy (platelet concentrate).

The underlying mechanism of TMH formation is unclear. One type forms immediately after ocular trauma, with the foveal rupture causing astute vision loss. Another blazon may result from the development of macular edema and cysts, which may induce delayed-onset TMH germination. With the regression of macular edema, shrinkage and closure of the hole may occur. Glial cell proliferation and epiretinal membrane formation are often the causes of a persistent open hole. Therefore, vitrectomy with membrane peeling might exist helpful and is a standard surgical procedure for treating TMH (six). Currently, PPV, ILM peeling or flap, and intraocular gas or silicone oil tamponade are the most ordinarily employed surgical procedures for TMH treatment (v). Ghoraba et al. concluded that gas tamponade is more successful than silicone oil tamponade for the anatomical closure and VA improvement of TMH (30). Intraocular gas tamponade is a crucial component of the surgical procedure for TMH repair. Higher rates of TMH closure were observed with C3F8, SF6, or C2F6 ocular tamponades, which could result from the extended amount of fourth dimension the C3F8, SF6, or C2F6 lasts in the vitreous cavity. In this meta-analysis, the TMH closure rate and VA improvement rate in the C3F8/SF6/C2F6 tamponade group showed improve outcomes than that in the air tamponade group.

Adjunctive therapies are oftentimes used together with surgery to accelerate hole closure (28, twoscore, 41). Rubin et al. used TGF-β2 in 12 eyes during vitrectomy and finally achieved a closure charge per unit of 67% in eight eyes (41). Garca-Arum et al. constitute that the intraoperative awarding of platelet concentrate in combination with vitrectomy may aid ameliorate anatomic and visual outcomes (40). As shown by our meta-analysis, platelet concentrate was a potential factor that afflicted visual improvement. However, studies are unlikely to be designed to evaluate adjunctive therapies, which are also seldom implemented today.

Spontaneous TMH Closure

TMH has been shown to close without any handling, unremarkably between 1 and 6 months after the trauma incident (viii, 9). The closure and VA improvement rates were 0.37 and 0.39, respectively, like to those reported in previous publications. In our meta-analysis, over 80% of the patients with TMH achieved closure within 6 months. The mechanism of spontaneous closure is of great interest. Why does TMH have a higher spontaneous closure rate than other types of MH? The fact that TMH patients are young and take a healthy vitreous gel and a firm vitreofoveal attachment may account for the high rate of spontaneous closure. Indeed, young age, modest hole size, cystic edema at the edge of the MH, and no posterior vitreous detachment have been recognized equally possible features affecting spontaneous closure (7, 48).

In addition, it should exist noted that 17 eyes developed obvious pigsty enlargement and ii eyes showed retinal detachment (43, 44). In v studies, 134 patients received supportive drugs (such as Sanqi Panax notoginseng for injection, compound anisodine hydrobromide injection, inosine tablets, or iodizedlecithin) to prepare the optic nerve and promote retinal microcirculation. However, experimental or clinical proof about their efficacy is defective.

Limitations

This meta-analysis has some limitations. Starting time, loftier heterogeneity existed in some outcomes, and many factors could have led to heterogeneity, such as the size of MH, dissimilar types of surgery, and interval from injury to surgery. However, the complete data were inappreciably accessed for subgroup assay, and the factors were relative to handling decisions. Second, since the studies included were retrospective and prospective observational studies and non RCTs, the comparison betwixt the surgery and observation groups was based on data with a discrepant baseline. Therefore, given the limitations mentioned to a higher place, RCTs are needed in the future to evaluate the effectiveness and safety of surgery and observation for TMH. Therefore, we will update our meta-analysis if RCTs are performed in future.

Conclusions

In conclusion, our systematic review and meta-analysis provides evidence that, compared with observation, surgery leads to higher TMH closure and VA comeback rates. Vitrectomy is an effective and safety handling method for TMH. The management guidelines for TMH in pediatric patients and the factors affecting the related outcomes need further description.

Data Availability Argument

The original contributions presented in the study are included in the article/Supplementary Material, farther inquiries tin be directed to the corresponding author.

Author Contributions

QZ, YX, and HL: conceptualization and design. QZ, HF, and ZF: literature search, information extraction, quality assessment, and statistical analysis. QZ: manuscript writing. HY: supervision. All authors approved the last version of the manuscript.

Funding

This work was supported by the National Nature Science Foundation of China (Grant Number: 81774371).

Conflict of Interest

The authors declare that the research was conducted in the absenteeism of any commercial or financial relationships that could be construed as a potential conflict of interest.

Publisher's Annotation

All claims expressed in this article are solely those of the authors and practice not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Whatever production that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.

Supplementary Fabric

The Supplementary Material for this article can be found online at: https://www.frontiersin.org/articles/x.3389/fmed.2021.735968/full#supplementary-material

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