Correction of Refractive Error Surprises After Cataract Surgery in Adults

Refractive Errors Clinical Trial

Official title:

Correction of Refractive Error Surprises After Cataract Surgery in Adults

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06379477
• Other study ID #: refractive error surprises
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2024
• Source: Assiut University
• Contact: Abdelrahman M Saad, MSC
• Phone: +201067895256
• Email: arabasdm.23[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A refractive surprise can be defined as the failure to achieve the intended postoperative refractive target or the presentation of unexpected and, unwanted post-operative refractive error. It can cause anisometropia or dominance switch and is a source of patient dissatisfaction due to unmet expectations.The best way to manage refractive surprise is to prevent it. The 2017 NICE guidelines on the management of cataracts provide advice on prevention of refractive surprise through accurate biometry, A-constant optimisation, intraocular lens (IOL) formula selection and avoiding wrong lens implant errors.Benchmark standards for NHS cataract surgery dictate that 85% of eyes should be within 1 dioptre (D) and 55% within 0.5D of target spherical equivalent refraction following surgery.

Description:

Aim(s) of the Research: 1. detection of refractive surprises using autorefractometer, and corneal topography. 2. treatment of the resulting refractive error surprises.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 63
• Est. completion date: June 30, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 75 Years

Eligibility

Inclusion Criteria:

All adult patients scheduled for cataract surgery with:

• Symptomatizing patients with postoperative spherical error of more than 1 diopters.
• Symptomatizing patients with postoperative cylindrical error of more than 1 diopters.
• Symptomatizing patients with uncorrected distant visual acuity less than 6/24
• Symptomatizing patients with corrected distant visual acuity of less than 6/12
• Clear cornea. 6. Uneventful surgery.

Exclusion Criteria:

• Patients with complicated cataract.
• Raised intraocular pressure (IOP).
• Patients with pathologies of the posterior segment of the eye.
• Other causes of diminution of vision.

Related Conditions & MeSH terms

• Capsule Opacification
• Cataract
• Refractive Errors

Intervention

Procedure:
• Refractive surgeries
after primary phacoemulsification surgery any resulting refractive error surprises will be corrected with different refractive surgery options

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (7)

Abdelghany AA, Alio JL. Surgical options for correction of refractive error following cataract surgery. Eye Vis (Lond). 2014 Oct 16;1:2. doi: 10.1186/s40662-014-0002-2. eCollection 2014. — View Citation

Day AC, Donachie PH, Sparrow JM, Johnston RL; Royal College of Ophthalmologists' National Ophthalmology Database. The Royal College of Ophthalmologists' National Ophthalmology Database study of cataract surgery: report 1, visual outcomes and complications — View Citation

Gale RP, Saldana M, Johnston RL, Zuberbuhler B, McKibbin M. Benchmark standards for refractive outcomes after NHS cataract surgery. Eye (Lond). 2009 Jan;23(1):149-52. doi: 10.1038/sj.eye.6702954. Epub 2007 Aug 24. — View Citation

Iwase T, Tanaka N, Sugiyama K. Postoperative refraction changes in phacoemulsification cataract surgery with implantation of different types of intraocular lens. Eur J Ophthalmol. 2008 May-Jun;18(3):371-6. doi: 10.1177/112067210801800310. — View Citation

Khoramnia R, Auffarth G, Labuz G, Pettit G, Suryakumar R. Refractive Outcomes after Cataract Surgery. Diagnostics (Basel). 2022 Jan 19;12(2):243. doi: 10.3390/diagnostics12020243. — View Citation

Ladas JG, Stark WJ. Improving cataract surgery refractive outcomes. Ophthalmology. 2011 Sep;118(9):1699-700. doi: 10.1016/j.ophtha.2011.05.038. No abstract available. — View Citation

Moshirfar M, Thomson AC, Thomson RJ, Martheswaran T, McCabe SE. Refractive enhancements for residual refractive error after cataract surgery. Curr Opin Ophthalmol. 2021 Jan;32(1):54-61. doi: 10.1097/ICU.0000000000000717. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis and treatment of the resulting refractive error surprises	Rate of refractive error surprises	Baseline