Clinical trial NCT06379477: Correction of Refractive Error Surprises After Cataract Surgery in Adults
Official title: Correction of Refractive Error Surprises After Cataract Surgery in Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Refractive Errors
Keywords: refractive error surprises
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-04-23
Enrollment: 63
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: Aim(s) of the Research:

1. detection of refractive surprises using autorefractometer, and corneal topography.
2. treatment of the resulting refractive error surprises.

Eligibility criteria: 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.

Primary outcomes:
measure: Diagnosis and treatment of the resulting refractive error surprises
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Magdy M Mostafa, MD
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Mohamed S Hussien, MD
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Ali N Ryad, MD
role: STUDY_DIRECTOR
References:
citation: 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.
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. Eye (Lond). 2015 Apr;29(4):552-60. doi: 10.1038/eye.2015.3. Epub 2015 Feb 13.
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.
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.
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.
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.
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.