The Effect of Macular Hole Duration on Surgical Outcomes:  An Individual Participant Data Study of Randomized Controlled Trials

Declan C. Murphy; Mo  Al-Zubaidy; Noemi Lois; Neil Scott; David H  Steel; Jinfeng Qu; Mingwei Zhao; Srinivas Sadda; Sreekumar Manasa; Divya Agarwal; Atul Kumar; Prateek Kakkar; Serge Bourgault; Eric Tourville; Raul Velez-Montoya; Sergio E. Hernandez-Da Mota; J. Abdel  Ramirez-Estudillo; Jerzy Nawrocki; Zofia Anna Nawrocka; Clemens Lange; James Bainbridge; David Yorston; Mark Alberti; Morten la Cour; Ulrik Christensen; Kwok Kwan Ho Alvin; Macular Hole Duration Study Group

doi:10.1016/j.ophtha.2022.08.028

The Effect of Macular Hole Duration on Surgical Outcomes: An Individual Participant Data Study of Randomized Controlled Trials

Declan C. Murphy, Mo Al-Zubaidy , Noemi Lois, Neil Scott, David H Steel^* (Corresponding Author), Jinfeng Qu, Mingwei Zhao, Srinivas Sadda, Sreekumar Manasa, Divya Agarwal, Atul Kumar, Prateek Kakkar, Serge Bourgault, Eric Tourville, Raul Velez-Montoya, Sergio E. Hernandez-Da Mota, J. Abdel Ramirez-Estudillo, Jerzy Nawrocki, Zofia Anna Nawrocka, Clemens LangeJames Bainbridge, David Yorston, Mark Alberti, Morten la Cour, Ulrik Christensen, Kwok Kwan Ho Alvin, Macular Hole Duration Study Group

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

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Abstract

Topic: To define the effect of symptom duration on outcomes in people undergoing surgery for idiopathic full thickness macular holes (iFTMH) by means of an individual participant data (IPD) study of randomised controlled trials (RCT). The outcomes assessed were primary iFTMH closure and post-operative best corrected visual acuity (BCVA)

Clinical relevance: iFTMH are visually disabling with a prevalence of up to 0.5%. Untreated BCVA is typically reduced to 20/200. Surgery can close holes and improve vision. Symptom duration is thought to affect outcomes with surgery, but the effect unclear.

Methods: A systematic review identified eligible RCTs which included adults with iFTMH undergoing vitrectomy with gas tamponade where symptom duration, primary iFTMH closure and post-operative BCVA were recorded. Bibliographic databases were searched for articles published between 2000 and 2020. IPD was requested from eligible studies.

Results: 20 eligible RCTs were identified. Data was requested from all studies and obtained from 12 representing 940 eyes in total. Median symptom duration was 6-months (interquartile (IQR) range 3-10).

Primary closure was achieved in 81.5% of eyes. The was a linear relationship between predicted probability of closure and symptom duration. Multilevel logistic regression showed each additional month of duration was associated with 0.965 times lower odds of closure (95% CI: 0.935 to 0.996, p=0.026). Internal limiting membrane (ILM) peeling, intra-operative ILM flap use, better pre-operative BCVA, face-down positioning and smaller iFTMH size were associated with increased odds of primary closure.

Mean post-operative BCVA in eyes achieving primary closure was 0.52 logMAR (20/66). Multilevel logistic regression showed for eyes achieving primary iFTMH closure, each additional month of symptom duration was associated with worsening BCVA by 0.008 logMAR units (95% CI: 0.005 to 0.011, p<0.001) (i.e., approximately 1 ETDRS letter loss per two months). ILM flaps, intra-ocular tamponade using long-acting gas, better pre-operative BCVA, smaller iFTMH size and phakic status were also associated with improved post-operative BCVA.

Conclusions:

Symptom duration was independently associated with both anatomical and visual outcomes in persons undergoing surgery for iFTMH. Time to surgery for iFTMHs should be minimised and care pathways designed to enable this.

Original language	English
Pages (from-to)	152-163
Number of pages	12
Journal	Ophthalmology
Volume	130
Issue number	2
Early online date	19 Jan 2023
DOIs	https://doi.org/10.1016/j.ophtha.2022.08.028
Publication status	Published - 1 Feb 2023

Bibliographical note

Funding Information:
Obtained funding: N/A; Study was performed as part of the authors' regular employment duties. No additional funding was provided.

Data Availability Statement

Supplemental material available at www.aaojournal.org.

Keywords

Macular hole
randomised controlled trial
symptom duration
closure
visual acuity
individual participant analysis

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Cite this

Murphy, D. C., Al-Zubaidy , M., Lois, N., Scott, N., Steel, D. H., Qu, J., Zhao, M., Sadda, S., Manasa, S., Agarwal, D., Kumar, A., Kakkar, P., Bourgault, S., Tourville, E., Velez-Montoya, R., Hernandez-Da Mota, S. E., Ramirez-Estudillo, J. A., Nawrocki, J., Nawrocka, Z. A., ... Macular Hole Duration Study Group (2023). The Effect of Macular Hole Duration on Surgical Outcomes: An Individual Participant Data Study of Randomized Controlled Trials. Ophthalmology, 130(2), 152-163. https://doi.org/10.1016/j.ophtha.2022.08.028

Murphy, DC, Al-Zubaidy , M, Lois, N, Scott, N, Steel, DH, Qu, J, Zhao, M, Sadda, S, Manasa, S, Agarwal, D, Kumar, A, Kakkar, P, Bourgault, S, Tourville, E, Velez-Montoya, R, Hernandez-Da Mota, SE, Ramirez-Estudillo, JA, Nawrocki, J, Nawrocka, ZA, Lange, C, Bainbridge, J, Yorston, D, Alberti, M, la Cour, M, Christensen, U, Ho Alvin, KK & Macular Hole Duration Study Group 2023, 'The Effect of Macular Hole Duration on Surgical Outcomes: An Individual Participant Data Study of Randomized Controlled Trials', Ophthalmology, vol. 130, no. 2, pp. 152-163. https://doi.org/10.1016/j.ophtha.2022.08.028

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abstract = "Topic: To define the effect of symptom duration on outcomes in people undergoing surgery for idiopathic full thickness macular holes (iFTMH) by means of an individual participant data (IPD) study of randomised controlled trials (RCT). The outcomes assessed were primary iFTMH closure and post-operative best corrected visual acuity (BCVA)Clinical relevance: iFTMH are visually disabling with a prevalence of up to 0.5%. Untreated BCVA is typically reduced to 20/200. Surgery can close holes and improve vision. Symptom duration is thought to affect outcomes with surgery, but the effect unclear.Methods: A systematic review identified eligible RCTs which included adults with iFTMH undergoing vitrectomy with gas tamponade where symptom duration, primary iFTMH closure and post-operative BCVA were recorded. Bibliographic databases were searched for articles published between 2000 and 2020. IPD was requested from eligible studies.Results: 20 eligible RCTs were identified. Data was requested from all studies and obtained from 12 representing 940 eyes in total. Median symptom duration was 6-months (interquartile (IQR) range 3-10).Primary closure was achieved in 81.5% of eyes. The was a linear relationship between predicted probability of closure and symptom duration. Multilevel logistic regression showed each additional month of duration was associated with 0.965 times lower odds of closure (95% CI: 0.935 to 0.996, p=0.026). Internal limiting membrane (ILM) peeling, intra-operative ILM flap use, better pre-operative BCVA, face-down positioning and smaller iFTMH size were associated with increased odds of primary closure.Mean post-operative BCVA in eyes achieving primary closure was 0.52 logMAR (20/66). Multilevel logistic regression showed for eyes achieving primary iFTMH closure, each additional month of symptom duration was associated with worsening BCVA by 0.008 logMAR units (95% CI: 0.005 to 0.011, p<0.001) (i.e., approximately 1 ETDRS letter loss per two months). ILM flaps, intra-ocular tamponade using long-acting gas, better pre-operative BCVA, smaller iFTMH size and phakic status were also associated with improved post-operative BCVA.Conclusions:Symptom duration was independently associated with both anatomical and visual outcomes in persons undergoing surgery for iFTMH. Time to surgery for iFTMHs should be minimised and care pathways designed to enable this.",

keywords = "Macular hole, randomised controlled trial, symptom duration, closure, visual acuity, individual participant analysis",

author = "Murphy, {Declan C.} and Mo Al-Zubaidy and Noemi Lois and Neil Scott and Steel, {David H} and Jinfeng Qu and Mingwei Zhao and Srinivas Sadda and Sreekumar Manasa and Divya Agarwal and Atul Kumar and Prateek Kakkar and Serge Bourgault and Eric Tourville and Raul Velez-Montoya and {Hernandez-Da Mota}, {Sergio E.} and Ramirez-Estudillo, {J. Abdel} and Jerzy Nawrocki and Nawrocka, {Zofia Anna} and Clemens Lange and James Bainbridge and David Yorston and Mark Alberti and {la Cour}, Morten and Ulrik Christensen and {Ho Alvin}, {Kwok Kwan} and {Macular Hole Duration Study Group}",

note = "Funding Information: Obtained funding: N/A; Study was performed as part of the authors' regular employment duties. No additional funding was provided. ",

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doi = "10.1016/j.ophtha.2022.08.028",

language = "English",

volume = "130",

pages = "152--163",

journal = "Ophthalmology",

issn = "0161-6420",

publisher = "Elsevier Inc.",

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TY - JOUR

T1 - The Effect of Macular Hole Duration on Surgical Outcomes

T2 - An Individual Participant Data Study of Randomized Controlled Trials

AU - Murphy, Declan C.

AU - Al-Zubaidy , Mo

AU - Lois, Noemi

AU - Scott, Neil

AU - Steel, David H

AU - Qu, Jinfeng

AU - Zhao, Mingwei

AU - Sadda, Srinivas

AU - Manasa, Sreekumar

AU - Agarwal, Divya

AU - Kumar, Atul

AU - Kakkar, Prateek

AU - Bourgault, Serge

AU - Tourville, Eric

AU - Velez-Montoya, Raul

AU - Hernandez-Da Mota, Sergio E.

AU - Ramirez-Estudillo, J. Abdel

AU - Nawrocki, Jerzy

AU - Nawrocka, Zofia Anna

AU - Lange, Clemens

AU - Bainbridge, James

AU - Yorston, David

AU - Alberti, Mark

AU - la Cour, Morten

AU - Christensen, Ulrik

AU - Ho Alvin, Kwok Kwan

AU - Macular Hole Duration Study Group

N1 - Funding Information: Obtained funding: N/A; Study was performed as part of the authors' regular employment duties. No additional funding was provided.

PY - 2023/2/1

Y1 - 2023/2/1

N2 - Topic: To define the effect of symptom duration on outcomes in people undergoing surgery for idiopathic full thickness macular holes (iFTMH) by means of an individual participant data (IPD) study of randomised controlled trials (RCT). The outcomes assessed were primary iFTMH closure and post-operative best corrected visual acuity (BCVA)Clinical relevance: iFTMH are visually disabling with a prevalence of up to 0.5%. Untreated BCVA is typically reduced to 20/200. Surgery can close holes and improve vision. Symptom duration is thought to affect outcomes with surgery, but the effect unclear.Methods: A systematic review identified eligible RCTs which included adults with iFTMH undergoing vitrectomy with gas tamponade where symptom duration, primary iFTMH closure and post-operative BCVA were recorded. Bibliographic databases were searched for articles published between 2000 and 2020. IPD was requested from eligible studies.Results: 20 eligible RCTs were identified. Data was requested from all studies and obtained from 12 representing 940 eyes in total. Median symptom duration was 6-months (interquartile (IQR) range 3-10).Primary closure was achieved in 81.5% of eyes. The was a linear relationship between predicted probability of closure and symptom duration. Multilevel logistic regression showed each additional month of duration was associated with 0.965 times lower odds of closure (95% CI: 0.935 to 0.996, p=0.026). Internal limiting membrane (ILM) peeling, intra-operative ILM flap use, better pre-operative BCVA, face-down positioning and smaller iFTMH size were associated with increased odds of primary closure.Mean post-operative BCVA in eyes achieving primary closure was 0.52 logMAR (20/66). Multilevel logistic regression showed for eyes achieving primary iFTMH closure, each additional month of symptom duration was associated with worsening BCVA by 0.008 logMAR units (95% CI: 0.005 to 0.011, p<0.001) (i.e., approximately 1 ETDRS letter loss per two months). ILM flaps, intra-ocular tamponade using long-acting gas, better pre-operative BCVA, smaller iFTMH size and phakic status were also associated with improved post-operative BCVA.Conclusions:Symptom duration was independently associated with both anatomical and visual outcomes in persons undergoing surgery for iFTMH. Time to surgery for iFTMHs should be minimised and care pathways designed to enable this.

AB - Topic: To define the effect of symptom duration on outcomes in people undergoing surgery for idiopathic full thickness macular holes (iFTMH) by means of an individual participant data (IPD) study of randomised controlled trials (RCT). The outcomes assessed were primary iFTMH closure and post-operative best corrected visual acuity (BCVA)Clinical relevance: iFTMH are visually disabling with a prevalence of up to 0.5%. Untreated BCVA is typically reduced to 20/200. Surgery can close holes and improve vision. Symptom duration is thought to affect outcomes with surgery, but the effect unclear.Methods: A systematic review identified eligible RCTs which included adults with iFTMH undergoing vitrectomy with gas tamponade where symptom duration, primary iFTMH closure and post-operative BCVA were recorded. Bibliographic databases were searched for articles published between 2000 and 2020. IPD was requested from eligible studies.Results: 20 eligible RCTs were identified. Data was requested from all studies and obtained from 12 representing 940 eyes in total. Median symptom duration was 6-months (interquartile (IQR) range 3-10).Primary closure was achieved in 81.5% of eyes. The was a linear relationship between predicted probability of closure and symptom duration. Multilevel logistic regression showed each additional month of duration was associated with 0.965 times lower odds of closure (95% CI: 0.935 to 0.996, p=0.026). Internal limiting membrane (ILM) peeling, intra-operative ILM flap use, better pre-operative BCVA, face-down positioning and smaller iFTMH size were associated with increased odds of primary closure.Mean post-operative BCVA in eyes achieving primary closure was 0.52 logMAR (20/66). Multilevel logistic regression showed for eyes achieving primary iFTMH closure, each additional month of symptom duration was associated with worsening BCVA by 0.008 logMAR units (95% CI: 0.005 to 0.011, p<0.001) (i.e., approximately 1 ETDRS letter loss per two months). ILM flaps, intra-ocular tamponade using long-acting gas, better pre-operative BCVA, smaller iFTMH size and phakic status were also associated with improved post-operative BCVA.Conclusions:Symptom duration was independently associated with both anatomical and visual outcomes in persons undergoing surgery for iFTMH. Time to surgery for iFTMHs should be minimised and care pathways designed to enable this.

KW - Macular hole

KW - randomised controlled trial

KW - symptom duration

KW - closure

KW - visual acuity

KW - individual participant analysis

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