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Status unknownNCT06379477Updated Apr 23, 2024

Correction of Refractive Error Surprises After Cataract Surgery in Adults

An interventional study of Refractive surgeries in Refractive Errors, sponsored by Assiut University. Status unknown. Open to participants aged 55 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-04-23.

Sponsored by Assiut University · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Apr 2024), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
55 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.
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Conditions studied

  • Refractive Errors

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Keywords

  • refractive error surprises
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In context

Refractive Errors

427 studies on the registry are indexed under Refractive Errors; 62 are open to participants now.

This study's planned enrollment of 63 is below the median of 81 across 307 interventional studies indexed under Refractive Errors.

Browse Refractive Errors studies →

Lead sponsor

Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
55 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
63 participants (estimated)

Study arms

  • Active comparator
    Corneal refractive surgery

    Among patients scheduled for cataract surgery, Group I; will undergo Corneal refractive surgery to correct any post-operative refractive surprises.

    Procedure: Refractive surgeries

  • Active comparator
    IOL exchange

    Among patients scheduled for cataract surgery, Group II; will undergo IOL exchange to correct any post-operative refractive surprises.

    Procedure: Refractive surgeries

  • Active comparator
    Piggyback sulcus IOL

    Among patients scheduled for cataract surgery, Group III; will undergo Piggyback sulcus IOL to correct any post-operative refractive surprises.

    Procedure: Refractive surgeries

Interventions

  • ProcedureRefractive surgeries

    after primary phacoemulsification surgery any resulting refractive error surprises will be corrected with different refractive surgery options

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What researchers measure

Primary outcomes

  1. Diagnosis and treatment of the resulting refractive error surprises

    Rate of refractive error surprises

    Time frame: Baseline

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 26605349 ↗
  • 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. PubMed 25679413 ↗
  • 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. PubMed 17721503 ↗
  • 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. PubMed 35204334 ↗
  • 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. PubMed 33122488 ↗
  • 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. PubMed 21889661 ↗
  • 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. PubMed 18465719 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06379477
Lead sponsor
Assiut University
Responsible party
Abdelrahman Mohamed saad (ophthalmology specialist at ophthalmology department Assiut University hospital, Assiut University) — Principal investigator
First posted
Apr 23, 2024
Start date
Jun 1, 2024 (estimated)
Primary completion
May 31, 2025 (estimated)
Completion
Jun 30, 2025 (estimated)
Last update
Apr 23, 2024

Study contacts

Abdelrahman M Saad, MSC
Contact
arabasdm.23@gmail.com
+201067895256
Magdy M Mostafa, MD
study director · Assiut University
Mohamed S Hussien, MD
study director · Assiut University
Ali N Ryad, MD
study director · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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