Improving ROP Management: Insights from a Comparative Analysis of Screening and Treatment Modalities in a Tertiary Hospital, Pakistan

doi:10.21203/rs.3.rs-5041388/v1

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Improving ROP Management: Insights from a Comparative Analysis of Screening and Treatment Modalities in a Tertiary Hospital, Pakistan

https://doi.org/10.21203/rs.3.rs-5041388/v1

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BACKGROUND

The principal objective of our study is to evaluate the characteristics of babies with type 1 ROP, screening practices and treatment trends in a tertiary care centre in Pakistan.

METHODS

This prospective study at Mayo Hospital, Lahore (July 2022–July 2024), included 89 preterm infants with type 1 ROP, selected using non-probability sampling. Infants were categorized based on international (GA < 32weeks or BW < 1500g) and local screening criteria (GA < 35 weeks or BW < 2000g), and treatment outcomes were evaluated across three groups: Anti-VEGF, combination therapy (Anti-VEGF followed by laser), and laser therapy. Statistical analysis was performed using SPSS version 27.0, employing Chi-square and Fisher Exact test for categorical variables. Statistical significance was set at p < 0.05.

RESULTS

Out of 355 infants screened, 89 (25.1%) met the inclusion criteria for type 1 ROP. The cohort included 55 males (61.8%) and 34 females (38.2%), with a mean gestational age of 31.31 weeks and a mean birth weight of 1602.25 grams. Zone 1 ROP was found in 36% of cases, associated with lower birth weight (P = 0.029) and earlier gestational age (P = 0.037), while Zone 2 ROP, found in 64%, was linked to higher birth weight and later gestational age. Zone 1 infants were more likely to receive anti-VEGF or combination therapy, whereas Zone 2 infants predominantly received laser therapy (p < 0.000). Preterm infants (born before 32 weeks) mostly received Anti-VEGF or combination therapy, while those with higher birth weights primarily received laser therapy (p < 0.010). Among the treated babies, 63 (70.8%) met international screening criteria and were more likely to have Zone 1 ROP and receive Anti-VEGF or combination therapy. Conversely, 26 (29.2%) did not meet these criteria, had predominantly Zone 2 ROP and were more likely to receive laser therapy (p = 0.007).

CONCLUSION

International screening criteria effectively identify severe type 1 ROP cases, particularly Zone 1, which often require Anti-VEGF therapy. Local criteria capture additional cases, predominantly Zone 2, which are more likely to need laser treatment. These findings highlight the need for tailored screening and treatment approaches to improve ROP management and outcomes for preterm infants

ROP

Type 1 ROP

Anti-VEGF therapy

Laser therapy

Retinopathy of prematurity (ROP) is a disorder of retinal vascularisation that affects infants with a history of premature birth or low birth weight. ROP is one of the leading causes of preventable blindness in infants and occurs in 43–68% of preterm infants with low birth weight. ⁽¹⁾

Enhanced neonatal care in low- and middle-income countries (LMICs) has significantly increased the survival rates of preterm and low birth weight infants. However, lack of awareness of ROP and insufficient diagnostic and treatment facilities, have also increased the risk of ROP in LMIC like Pakistan ⁽²⁾. A 2016 study conducted in Lahore reported a 16% prevalence rate ⁽³⁾. Another study concluded that the prevalence of retinopathy of prematurity in premature neonates visiting Sir Ganga Ram Hospital Lahore was 27% ⁽⁴⁾. Routine screening for ROP is essential as timely detection and treatment can significantly reduce the risk of blindness. All countries with high Human Development Index, have screening criteria that fall within a gestational age (GA) of ≤ 32 weeks or a birth weight (BW) of ≤ 1500 g ⁽⁵⁾. However, local guidelines, such as those from the Ophthalmological Society of Pakistan, recommend broader criteria to better reflect regional neonatal care practices ⁽⁵⁾.

Multiple studies have led to current guidelines for the treatment of ROP. The CRYO-ROP study established cryotherapy as the preferred treatment for Type 1 ROP ^{(6, 7)}. The ET-ROP study set early laser photocoagulation as the gold standard treatment for type 1 ROP, and BEAT-ROP introduced intravitreal injections of anti-vascular endothelial growth factor (VEGF) as a means to stop the progression of severe ROP and promote physiologic intra retinal vascularisation, theoretically reducing the potential for visual field loss ^{(8, 9)}. Compared with laser treatment, anti-VEGF injection is shorter and less stressful for neonates, and it may not require peripheral retinal ablation ⁽¹⁰⁾.

The study aims to compare local vs international criteria for ROP screening and treatment modalities employed in a tertiary care hospital in Pakistan. This study intends to provide insights into the current practices and potential areas for improvement in ROP management within the Pakistani healthcare system.

This study represents a prospective, observational cohort analysis conducted on infants referred for retinopathy of prematurity (ROP) screening at the Ophthalmology Department, Mayo Hospital, Lahore, from July 2022 to July 2024. Utilizing non-probability consecutive sampling, sample size of 75 participants was calculated.

Our inclusion criteria consisted of premature babies with a gestational age of 35 weeks or less, or birth weight of 2000 grams or less, or both, who were diagnosed with type 1 ROP. Type 1 ROP is defined as per International Classification for Retinopathy of Prematurity ICROP 3 (revised)—including zone I any stage ROP with plus disease, zone I stage 3 ROP with or without plus disease, or zone II stage 2 or 3 ROP with plus disease. Exclusion criteria encompassed those with type 2 ROP defined as zone 1 or 2 without plus disease or zone 2 stage 3 without plus disease, severe ongoing comorbidities or those lost to follow-up.

Examinations involved pupil dilation with a cocktail of dilating drops containing phenylephrine 2.5%, cyclopentolate 0.5% eye drops and the use of an infantile eye speculum to facilitate visualization. Each infant was assessed for ROP using indirect ophthalmoscopy by a trained pediatric ophthalmologist with a + 28D condensing lens and scleral depression. The ICROP 3 guidelines were used to document the stage of the disease, location by zone, signs of plus disease, and signs of regression.

To evaluate the effectiveness of screening criteria, babies were divided into 2 groups:

1. Falling within international criteria: Babies that had a gestation age of 32 weeks or below or a birth weight of 1500g or below.

2. Falling outside international criteria: Babies with a gestational age between 32 + 1 and 35 weeks or a birth weight between 1501 and 2000g.

Babies with aggressive posterior disease were treated with Anti-VEGF therapy, ranibizumab Injection (2.5 mg in 0.05 ml) under aseptic technique, preceded by antibiotic eye drops and post-procedure 2 hours monitoring. Weekly follow-up was carried out till the regression of the disease. In babies that did not achieve disease regression diode laser was applied. Babies with peripheral disease were treated with diode laser therapy as initial therapy and followed up every 2 weeks till disease regression.

Thus, there are 3 treatment groups in our study:

1. Anti-VEGF only group

2. Combination therapy group: Anti-VEGF followed by laser

3. Laser only group

Statistical Analysis

Data were entered into Microsoft Excel and analysed using SPSS version 27.0. Descriptive statistics (percentages, frequencies, means, and standard deviations) summarized the data. Chi-square and Fisher Exact tests evaluated categorical variables, while Independent T tests and relevant correlations assessed numerical variables. Statistical significance was set at p < 0.05. Gestational age and birth weight were categorized based on international and local screening criteria, i.e., < 32 weeks GA or < 1500 g BW and < 35 weeks GA or < 2000 g BW, respectively.

Basic Demographics

Out of a total of 355 babies screened between July 2022 and July 2024, we found 89 (25.1%) babies with type I ROP meeting our inclusion criteria. These 89 participants, with 55 (61.8%) males and 34 (38.2%) females. Of these, 52 (58.4%) were from urban areas and 37 (41.6%) from rural areas. The mean gestational age was 31.31 weeks (± 2.77), and the mean birth weight was 1602.25 grams (± 445.23).

Evaluation of Screening Criteria

We found that 63 (70.8%) of the treated babies fell within international screening criteria. Conversely, 26 (29.2%) of the treated babies did not meet these international criteria. Details mentioned in Table 1.

Babies meeting international criteria were significantly more likely to have Zone 1 ROP (44.4% vs. 15.4%, P = 0.009), while those missed by international criteria predominantly had Zone 2 ROP (84.6% vs. 55.6%). Regarding treatment, babies meeting international criteria were more often treated with Anti-VEGF (20.6% vs. 7.7%) and Combination therapy (47.6% vs. 23.1%), while those missed by international criteria primarily received Laser treatment (69.2% vs. 31.7%) (P = 0.007). This suggests that the international criteria effectively identify more severe ROP cases (Zone 1) and infants needing anti-VEGF treatments, whereas the local criteria capture additional cases that primarily require Laser treatment.

Table 1

Characteristics of babies falling within and outside international screening guidelines
Characteristic	Subgroup	Falling within international criteria n = 63	Falling outside International Criteria n = 26	Significance
Zone of ROP	Zone 1	28(44.4%)	4(15.4%)	P = 0.009
Zone of ROP	Zone 2	35(55.6%)	22(84.6%)	P = 0.009
Treatment Group	Anti VEGF only group	14(22.2%)	2(7.7%)	P = 0.006
	Combination group	29(46%)	6(23.1%)
	Laser group	20(31.7%)	18(69.2%)

ROP Classification

The distribution of ROP zones was as follows: 32 infants (36%) had Zone 1 disease, 57 (64%) had Zone 2 disease. Details are mentioned in Table 2.

Zone of ROP was significantly associated with birth weight and gestational age groups (p < 0.05). Infants in Zone 1 are significantly more likely to be born before 32 weeks (84.4% vs. 57.9%, P = 0.037) and have a birth weight less than 1500 grams (43.8% vs. 33.3%, P = 0.029). Conversely, Zone 2 was found more in babies born between 32–35 weeks (31.6% vs. 12.5%) and over 35 weeks (10.5% vs. 3.1%), as well as in babies with birth weight over 2000 grams (19.3% vs. 0%). This suggests that Zone 2 disease is more likely to occur in older and heavier babies.

Table 2

Zones of ROP in different GA and BW categories
Characteristic	Subgroup	Zone 1 n = 32	Zone 2 n = 57	Significance
Gestational Age	< 32 weeks	27 (84.4%)	33 (57.9%)	P = 0.040
	32–35 weeks	4(12.5%)	18(31.6%)
	> 35 weeks	1(3.1%)	6(10.5%)
Birth weight	< 1500g	14(43.8%)	19(33.3%)	P = 0.016
	1501-2000g	18(56.3%)	27(47.4%)
	> 2000g	0	11(19.3%)

Distribution of ROP treatment

Of the 89 identified type I ROP babies, 38(42.7%) were treated with laser therapy after diagnosis and followed up after every 2 weeks until disease regression was achieved. 51 were given Anti-VEGF after diagnosis, of these 16 achieved disease regression in weekly follow up and 35 required laser therapy due to persistent disease. Details of screening and treatment outcomes are mentioned in Fig. 1, details of treatment modalities are mentioned in Table 3.

Babies with Zone 1 disease predominantly received Anti-VEGF (68.8%) or Combination therapy (54.3%), while most Zone 2 infants received Laser (94.7%), indicating significant differences by ROP zones (P = 0.000). For gestational age, babies born before 32 weeks mostly received Anti-VEGF (87.5%) and Combination therapy (77.1%), with fewer receiving Laser (50%) (P = 0.033).

In terms of birth weight, babies under 1500g were fairly evenly distributed across treatments, but those between 1501-2000g primarily received Combination therapy (60%) and Anti-VEGF (56.3%). Infants over 2000g mostly received Laser (26.3%), highlighting significant differences by birth weight (P = 0.010). This suggests Anti-VEGF and Combination therapy are more common in zone 1 ROP and among the most premature babies, while Laser therapy is more prevalent in zone 2, older, and heavier babies.

Table 3

Treatment Group analysis
Characteristic	Subgroup	Treatment group			Significance
		Anti-VEGF only N = 16	Combination N = 35	Laser only N = 38
Zone of ROP	Zone 1	11(68.8%)	19(54.3%)	2(5.3%)	P = 0.000
Zone of ROP	Zone 2	5(31.3%)	16(45.7%)	36(94.7%)	P = 0.000
Gestational Age	< 32 weeks	14(87.5%)	27(77.1%)	19(50%)	P = 0.033
	32–35 weeks	1 (6.3%)	6(17.1%)	15(39.5%)
	> 35 weeks	1 (6.3%)	2(5.7%)	4(10.5%)
Birthweight	< 1500g	6(37.5%)	14(40%)	13(34.2%)	P = 0.010
	1501-2000g	9(56.3%)	21(60%)	15(39.5%)
	> 2000g	1(6.3%)	0	10(26.3%)

In our study we found a high incidence of type 1 ROP and a significant disparity between local and international screening criteria for ROP as well as key associations between screening practices, zones of ROP and treatment modalities utilized. We found that 25% of screened babies had retinopathy of prematurity, which aligns with findings from other studies conducted in Lahore. For instance, a study at Hamid Latif Hospital, ⁽¹¹⁾ Lahore found a 28% ROP incidence, while a study at Ganga Ram Hospital, Lahore by Abdul Rauf et al. observed that 43 out of 160 screened babies developed ROP.⁽⁴⁾ In contrast, a 2016 study at Mayo Hospital reported a significantly lower ROP incidence of 15%.⁽³⁾ This variation can be attributed to advancements in neonatal intensive care, which have led to improved survival rates among preterm infants, as well as the implementation of enhanced screening protocols and diagnostic tools that have facilitated earlier detection of retinopathy of prematurity. ⁽¹²⁾ Additionally, studies at Shifa Hospital and Aga Khan University reported lower ROP incidences of 3.2% and 11.2%, respectively. ^{(13, 14)} These lower rates may be linked to improved neonatal intensive care and better-controlled oxygen therapy for premature infants in those healthcare settings.

Comparative international data suggests that the incidence of retinopathy of prematurity varies significantly between developed and developing regions. Studies from Iran and North India reported ROP incidence rates of 23.5% and 18.18% respectively among preterm infants, while a Chinese study found a 13.99% incidence of ROP requiring treatment.^(15–17) In contrast, developed countries like Poland exhibited a lower incidence, with only 6.1% of infants requiring ROP treatment.⁽¹⁸⁾ Similarly, the incidence of type 1 ROP in North America was reported to be 6%, markedly lower than the rate observed in our cohort.⁽¹⁹⁾ These disparities may be attributed to the more advanced neonatal intensive care services and improved screening and treatment modalities available in developed nations, which contribute to better management and prevention of ROP.

Regarding screening practices, we found that 29.2% of infants with Type 1 ROP would have been missed if only international screening criteria was applied, highlighting the importance of local criteria development and refinement. Ours is not the first study assessing ROP screening criteria suitability in Pakistan. A study conducted in our centre in 2017 to 2019 on 51 ROP blind children found that international criteria would have missed 4 (7.8%) of these children. ⁽²⁰⁾ Contrasting our results a study in Karachi from 2010 to 2012 found that no children developing ROP fell outside international screening guidelines. ⁽²⁾ Another study taking place in our centre also found only 4 infants > 32 weeks and 1 infant > 1500g in 2016. ⁽³⁾ Another study in Lahore in 2019 found international criteria would have missed 4(19%) infants based on GA and 2 (9%) infants based on BW. ⁽¹¹⁾ These studies combined with our results indicate a concerning trend of an increased amount of older and heavier babies presenting with ROP.

The importance of robust and extensive ROP screening programmes cannot be ignored in this era as the world goes through the third documented ROP epidemic. Unlike the first 2 waves this third wave mostly targets lower and lower middle-income countries like Pakistan where the rise in premature infant survival through increasing supplemental oxygen provision, coupled with a lack of ROP awareness, education in the general l population, lack of resources and loss to follow-up creates a dangerous breeding ground for this epidemic to go on rising unchecked ^{( 21)}. In these conditions, the need for an ROP screening guideline is paramount. This is why the number of infants missed by international screening criteria is concerning. While screening criteria are being lowered across the world (with general guidelines in the US being lowered to 30 weeks and 1500g in 2013 and UK guidelines being lowered to 32 weeks in 2022 from the 32 weeks and 1500g), our findings support a broadening of these parameters in our region.⁽²²⁾ The variation of screening criteria by region has been recommended before, as it was found that low and lower middle-income regions tended to find ROP in older and heavier babies. Sub optimal neonatal care services may be to blame for this disparity, as it has been consistently noted that countries lower on the human development index require guidelines more extensive than the standard 32 weeks and 1500g and require extensive studies and data to fine tune these guidelines to suit their populations needs. ⁽²³⁾ This is why the Ophthalmological Society of Pakistan (OSP, December 2019) recommends screening at ≤ 35 weeks or ≤ 2000g, which our findings heavily support ⁽²⁰⁾.

We found zones of ROP to be significantly associated with GA, BW along with treatment required. We found babies weighing over 2000 grams and with a gestational age of > 35 weeks were more likely to have zone 2 ROP and receive laser therapy as their initial treatment. In contrast, babies with zone 1 disease typically had lower birth weights (< 1500 grams or 1500–2000 grams) and earlier gestational ages (< 32 weeks), making them more likely to receive anti-VEGF treatment initially. Other studies also found higher birth weight and age leading to zone 2 ROP and laser therapy and zone 1 disease got anti-VEGF.^{(17, 18)} Real world data reports that Anti-VEGF is preferred for zone 1 ROP and zone 2 posterior disease, while laser is better for zone 2 ROP.⁽²⁴⁾ Although studies such as the BEAT-ROP have found anti-VEGF treatment to be more effective in zone 1 than zone 2 ROP, we found no significant difference in disease regression after initial anti-VEGF in both zones.⁽⁹⁾ Two-thirds of zone 1 ROP and three-fourth of zone 2 ROP babies initially treated with anti-VEGF failed to achieve disease regression and required laser treatment on follow up. No significant difference between the two groups was noted.

We found that 68.6% of babies initially treated with anti-VEGF required additional laser therapy on follow up, while all babies initially treated with laser achieved disease regression. Similar findings were observed in other studies ²⁵⁾. However, across the board, a majority of the babies initially treated with anti-VEGF, needed further laser intervention. This highlights the importance of robust follow-up programs during anti-VEGF ROP treatment.

Overall, it is very encouraging that all of the babies treated for type 1 ROP in our centre managed to achieve disease regression. The main strength of this study is that we studied a large population compared to previous studies, offering important insights into ROP incidence and evaluation of screening practices.

Our study has several limitations, Firstly, the relatively small sample size of 89 participants limits the generalizability of our findings. The single-centre design introduces potential selection bias, restricting the applicability of our findings to other settings with different neonatal care practices and screening protocols. The short follow up duration may have been insufficient to fully evaluate the long-term implications and sustainability of the treatment modalities examined. It should be noted that we employed ranibizumab as the anti-VEGF treatment in our study. Recent network meta-analysis has noted that ranibizumab has significantly lower success rate than bevacizumab, future studies should take into account the effectiveness of different anti-VEGF agents ⁽²⁶⁾.

Our findings strongly support the continued use of broad screening practices in Pakistan. For treatment, we recommend that heavier and older babies with zone 2 ROP should receive laser therapy. Younger, lighter babies with zone 1 ROP should initially receive anti-VEGF treatment and be closely monitored for the need for additional intervention.

ROP: Retinopathy of Prematurity
VEGF: Vascular Endothelial Growth Factor
GA: Gestational Age
BW: Birth Weight
LMIC: Low- and Middle-Income Countries
ICROP: International Classification for Retinopathy of Prematurity
SPSS: Statistical Package for the Social Sciences
OSP: Ophthalmological Society of Pakistan
SD: Standard Deviation
P: p-value (Probability value)

Ethics approval and consent to participate
This study was approved by the Ethical Review Board of the College of Ophthalmology and Allied Vision Sciences, Lahore, under reference number 838/24. Written informed consent was obtained from the parents or legal guardians of all participants included in the study. All procedures performed were in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Consent for publication
Not applicable

Competing interests

The authors declare that they have no competing interests

Funding

None

Author Contribution

MM took part in project conceptualization, data collection, manuscript writing and editing, AA took part in project conceptualization, data collection, manuscript writing and editing, LSM took part in project conceptualization,data collection, manuscript writing and editing, AP took part in data collection, manuscript writing and editing, RK took part in data analysis, manuscript writing and editing, NS took part in data analysis, manuscript writing and editing. All authors read and approved the final manuscript.

Acknowledgements

Not applicable

Data Availability

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

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You are reading this latest preprint version

Improving ROP Management: Insights from a Comparative Analysis of Screening and Treatment Modalities in a Tertiary Hospital, Pakistan

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Version 1

Abstract

BACKGROUND

METHODS

RESULTS

CONCLUSION

Figures

INTRODUCTION

METHODOLOGY

Statistical Analysis

RESULTS

DISCUSSION

CONCLUSION

Abbreviations

Declarations

Consent for publication
Not applicable

Competing interests

Funding

Author Contribution

Acknowledgements

Data Availability

References

Additional Declarations

Status:

Version 1

Improving ROP Management: Insights from a Comparative Analysis of Screening and Treatment Modalities in a Tertiary Hospital, Pakistan

Status:

Version 1

Abstract

BACKGROUND

METHODS

RESULTS

CONCLUSION

Figures

INTRODUCTION

METHODOLOGY

Statistical Analysis

RESULTS

DISCUSSION

CONCLUSION

Abbreviations

Declarations

Consent for publication Not applicable

Competing interests

Funding

Author Contribution

Acknowledgements

Data Availability

References

Additional Declarations

Status:

Version 1

Consent for publication
Not applicable