Abstract
Purpose
To better understand how bandage contact lenses (BCLs) are evaluated in clinical research studies following refractive procedures, such as Laser Assisted Sub-Epithelial Keratectomy (LASEK) and Photorefractive Keratectomy (PRK); or after a therapeutic treatment, such as Corneal Collagen Crosslinking (CCXL) for Keratoconus.
Methods
A series of detailed literature searches were performed in PubMed (using keywords, such as “PRK”, “LASEK” and “Corneal Collagen Crosslinking”) to identify published research studies conducted in human patients that had undergone either LASEK/PRK or CCXL for keratoconus within the last 10 years (2005-2015).
Exclusion criteria were set to remove studies that used a transepithelial CCXL procedure, or included cases of iatrogenic keratectasia. Additionally, papers not written in English were also excluded.
After applying the exclusion criteria, a total of 73 papers were carefully scrutinised to explore the following criteria:
1) Were the fitted BCLs named within each study? If so, what materials were these BCLs made from?
2) Was deposition of the BCLs monitored?
3) Was epithelial healing evaluated? If so, what methods of evaluation were used?
4) Was post-treatment pain, whilst wearing the BCLs, evaluated? If so, what methods of evaluation were used?
Results
A large proportion (31/73) of these published reports did not disclose which BCLs were fitted following these refractive/therapeutic procedures. A majority of studies (27/42) reported fitting at least one of the three current Food and Drug Administration (FDA) approved BCLs. Surprisingly, very few studies reported assessment of either BCL deposition (4/73) or epithelial healing (15/73). Of the studies that evaluated post-treatment pain whilst wearing the BCLs (25/73), the most common grading method involved the use of a numerical rating scale (13/25). Although some authors did not disclose when the BCLs were removed post-treatment (10/73), a majority of studies reported removing the BCLs after complete re-epithelialisation had occurred (36/73). The remaining studies (27/73) recorded that BCLs were removed a specific number of days after treatment.
Conclusion
Currently, there is little consensus in the published literature regarding how BCLs should be evaluated when fitted to patients after LASEK/PRK or CCXL for keratoconus. Further research needs to be conducted to develop an accepted protocol of assessments, which might include monitoring of BCL deposition, a recognised method of assessing epithelial healing and evaluation of post-operative pain whilst wearing BCLs. These factors are all important in determining whether a BCL should be left in situ, replaced for a fresh BCL or removed altogether. A more harmonious approach to evaluating the performance of BCLs, following either refractive or therapeutic procedures, would prove useful in delivering a high standard of patient care.
To better understand how bandage contact lenses (BCLs) are evaluated in clinical research studies following refractive procedures, such as Laser Assisted Sub-Epithelial Keratectomy (LASEK) and Photorefractive Keratectomy (PRK); or after a therapeutic treatment, such as Corneal Collagen Crosslinking (CCXL) for Keratoconus.
Methods
A series of detailed literature searches were performed in PubMed (using keywords, such as “PRK”, “LASEK” and “Corneal Collagen Crosslinking”) to identify published research studies conducted in human patients that had undergone either LASEK/PRK or CCXL for keratoconus within the last 10 years (2005-2015).
Exclusion criteria were set to remove studies that used a transepithelial CCXL procedure, or included cases of iatrogenic keratectasia. Additionally, papers not written in English were also excluded.
After applying the exclusion criteria, a total of 73 papers were carefully scrutinised to explore the following criteria:
1) Were the fitted BCLs named within each study? If so, what materials were these BCLs made from?
2) Was deposition of the BCLs monitored?
3) Was epithelial healing evaluated? If so, what methods of evaluation were used?
4) Was post-treatment pain, whilst wearing the BCLs, evaluated? If so, what methods of evaluation were used?
Results
A large proportion (31/73) of these published reports did not disclose which BCLs were fitted following these refractive/therapeutic procedures. A majority of studies (27/42) reported fitting at least one of the three current Food and Drug Administration (FDA) approved BCLs. Surprisingly, very few studies reported assessment of either BCL deposition (4/73) or epithelial healing (15/73). Of the studies that evaluated post-treatment pain whilst wearing the BCLs (25/73), the most common grading method involved the use of a numerical rating scale (13/25). Although some authors did not disclose when the BCLs were removed post-treatment (10/73), a majority of studies reported removing the BCLs after complete re-epithelialisation had occurred (36/73). The remaining studies (27/73) recorded that BCLs were removed a specific number of days after treatment.
Conclusion
Currently, there is little consensus in the published literature regarding how BCLs should be evaluated when fitted to patients after LASEK/PRK or CCXL for keratoconus. Further research needs to be conducted to develop an accepted protocol of assessments, which might include monitoring of BCL deposition, a recognised method of assessing epithelial healing and evaluation of post-operative pain whilst wearing BCLs. These factors are all important in determining whether a BCL should be left in situ, replaced for a fresh BCL or removed altogether. A more harmonious approach to evaluating the performance of BCLs, following either refractive or therapeutic procedures, would prove useful in delivering a high standard of patient care.
| Original language | English |
|---|---|
| Publication status | Published - 23 May 2016 |
| Event | European Academy of Optometry and Optics - Beuth University of Applied Sciences Luxemburger Strasse 10 Berlin 13353, Berlin, Germany Duration: 19 May 2016 → 22 May 2016 http://www.eaoo.info/filemanager/root/site_assets/documents/2016_berlin/eaoo_abstracts_2016_WEB.pdf |
Conference
| Conference | European Academy of Optometry and Optics |
|---|---|
| Country/Territory | Germany |
| City | Berlin |
| Period | 19/05/16 → 22/05/16 |
| Internet address |